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Tag Archives: PHA

Takeda Announces Completion of the Post-Marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS

-- No overall statistically significant increased risk of bladder cancer in patients ever exposed to pioglitazone in a completed 10-year epidemiological study

OSAKA, Japan, Aug. 29, 2014 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour, and Welfare (MHLW) / the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).1,2 This study was a 10-year epidemiology study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California (KPNC), and was designed to investigate whether patients exposed to pioglitazone were at an increased risk of bladder cancer.1 Findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone.2

The primary analysis found no association between the use of pioglitazone and the risk of bladder cancer.2 Additionally, no association was found between the risk of bladder cancer and the duration of pioglitazone use, increased cumulative dose of pioglitazone or the time since initiating pioglitazone.

In the five-year interim analysis published in Diabetes Care, a statistically significant increased risk among patients who used pioglitazone for two or more years was observed.1 However, the 10-year final analysis did not show any statistically significant findings of increased risk of bladder cancer with long term use of pioglitazone.2 The data will be shared with additional regulatory authorities in accordance with local requirements around the world, and final results will be submitted for publication in 2014.   

"The completion of this long-term study is a milestone in the history of pioglitazone," said Tom Harris, head, global regulatory affairs, Takeda. "The results of the study provide reassurance with regard to the use of pioglitazone and the risk of bladder cancer and further support the positive benefit risk profile of the product."

About Pioglitazone

Pioglitazone is approved as an agent to treat patients with Type 2 diabetes mellitus in more than ­­­100 countries world-wide. More than 27,000 subjects have been included in clinical trials, and globally the total patient-years of exposure since first launch (1999) is estimated to be in excess of more than 29 million. Pioglitazone as a treatment of Type 2 diabetes mellitus at the recommended doses provides a valuable treatment option, and has a well established safety profile. The benefits of good glycemic control associated with Type 2 diabetes mellitus outweigh the risks associated with therapy which are appropriately communicated and managed by the current product labelling.

Pioglitazone is a thiazolidinedione for the treatment of Type 2 diabetes in adults as an adjunct to diet and exercise.

Unlike many oral antidiabetic drugs, pioglitazone is not an insulin secretagogue. Pioglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism. Therefore, pioglitazone is a medication that depends on the presence of insulin for its mechanism of action, and it decreases insulin resistance in muscle and the liver, resulting in increased insulin-dependent glucose disposal as well as decreased hepatic glucose output.

Clinical studies demonstrate that pioglitazone improves insulin sensitivity in insulin-resistant patients. Pioglitazone enhances cellular responsiveness to insulin, increases insulin-dependent glucose disposal and improves hepatic sensitivity to insulin. In patients with Type 2 diabetes, the decreased insulin resistance produced by pioglitazone results in lower plasma glucose concentrations, lower plasma insulin concentrations, and lower HbA1c values. In controlled clinical trials, pioglitazone had an additive effect on glycemic control when used in combination with sulfonylurea, metformin, or insulin.

Important Safety Information

Contraindications

Initiation of ACTOS is contraindicated in patients with NYHA Class III or IV heart failure.

ACTOS is contraindicated in patients with known hypersensitivity to pioglitazone or any of its excipients so as to avoid inducing a potentially serious hypersensitivity reaction.

Warnings and Precautions

Fluid retention and cardiac failure: Thiazolidinediones, including ACTOS, can cause dose-dependent fluid retention, which may exacerbate or precipitate heart failure. After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, discontinuation of ACTOS must be considered. ACTOS should be used with caution in patients with cardiac dysfunction whose physical activity is markedly limited. Combination use with insulin may increase risk.

Hepatic effects: Post-marketing reports of hepatitis and hepatic dysfunction have been received. Very rarely these reports have involved hepatic failure, with and without a fatal outcome, although causality has not been established. Obtain liver tests before starting ACTOS and periodically thereafter. Pioglitazone therapy should not be initiated in patients with increased liver enzyme levels (ALT> 2.5x upper limit of normal) or with any other evidence of liver disease. Existing pioglitazone therapy should be discontinued if ALT levels are persistently higher than 3x the upper limit of normal, and symptoms suggesting hepatic dysfunction should cause the liver enzymes to be checked. Pending the results of laboratory investigations, the decision as to whether pioglitazone therapy should continue must be based on clinical judgment; in the presence of jaundice, drug therapy should be discontinued.

Weight gain: Weight gain was observed in clinical trials and has been seen in post-marketing experience with pioglitazone, so patient weight should be closely monitored.

Fractures: An increased incidence of bone fracture has been noted in female patients.

Bladder cancer: Some data suggest there may be an increased risk of bladder cancer in ACTOS users and also that the risk increases with duration of use. Do not use ACTOS in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria or urinary urgency as these may be due to bladder cancer.

Hypoglycemia: When ACTOS is used with insulin, a sulfonylurea or other oral hypoglycemic agents, hypoglycemia may occur.

Ovulation: Ovulation in premenopausal anovulatory women or women with polycystic ovarian syndrome may occur with ACTOS.

Macular edema: Post-marketing reports of new-onset or worsening diabetic macular edema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone. Physicians should consider the possibility of macular edema if a patient reports decreased visual activity.

Drug interactions: Use of ACTOS with CYP2C8 inducers or strong inhibitors may require dose adjustment.

Please refer to the Summary of Product Characteristics (SmPC) for ACTOS before prescribing.

ACTOS should be used according to the indication, posology and method of administration described in the SmPC.

Please consult with your local regulatory agency for approved labeling in your country.

About Type 2 diabetes

  • In 2013, 382 million people worldwide were living with Type 2 diabetes. By 2035 this number is expected to rise to 592 million.3
  • In 2013, the number of people with diabetes in Europe was estimated to be 56 million.4
  • The number of Type 2 diabetes patients is increasing in every country.3
  • In 2013, one in 10 deaths in adults in Europe was attributed to diabetes, representing over 600,000 people.3
  • Estimates indicate that more than EUR 108 billion* was spent on healthcare due to diabetes in the European region in 2013, accounting for over one-quarter of global healthcare expenditures due to diabetes.3
  • Because of the increasingly complex nature of this disease, all patients require treatment to be individualized to their needs.5 Each patient responds differently to medications, and healthcare providers often must combine multiple treatment options to help patients manage their disease.

*Based on conversion of USD 147 billion,3 where 1 EUR = 1.36035 USD as of 21 July 2014.

About Takeda's Diabetes Business

Takeda's heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, and developments of other fixed-dose combinations. The company's strong, diverse diabetes portfolio and available medications mark important milestones in Takeda's ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.

Contact:

Elissa J. Johnsen
+1-224-554-3185  
elissa.johnsen@takeda.com

References

[1] Lewis, JD., Ferrara, A., Peng, T., et al. The Risk of Bladder Cancer Among Diabetic Patients Treated with Pioglitazone: Interim Report of a Longitudinal Cohort Study. Diabetes Care 24, April 2011 34:4 923-929.

[2] Takeda Data on File. 2014. 

[3] International Diabetes Federation. IDF Atlas, sixth edition. Last accessed July 10, 2014. Available at: http://www.idf.org/diabetesatlas.

[4] International Diabetes Federation. Diabetes: Facts and figures. Last accessed July 10, 2014. Available at: http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures.

[5] Inzucchi SE, Bergenstal RM et al. Management of Hyperglycaemia in Type 2 Diabetes: A Patient-Centred Approach. Diabetes Care. 2012:35: (6):1364-1379.


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CAIDE Looks into the Future: New App from Merz Pharmaceuticals Assesses the Risk of Getting Dementia Within the Next 20 Years

FRANKFURT AM MAIN, Germany, Aug. 29, 2014 /PRNewswire/ -- The CAIDE Dementia Risk App from Merz Pharmaceuticals is available free of charge for people from 40 to 65 to calculate their individual risk for getting dementia within the next two decades. Using a traffic light color scheme, the App can also help physicians discuss preventive measures with patients at risk.

The new "CAIDE Dementia Risk App (Cardiovascular risk factors, Aging and Incidence of DEmentia) has been developed in collaboration with Karolinska Institutet in Stockholm and is available in the App Store for a free download. The CAIDE App may be used on an iPhone or iPad and comes in two versions: one for physicians and one for individuals. It is available in five languages: German, French, Spanish, Russian, and English as default.

CAIDE supports prevention of dementia 

After entering gender, date of birth, height and weight, cholesterol level, blood pressure, physical activity and years of education the App calculates the risk of getting dementia within the next 20 years. If the risk is in the normal range an orange bar appears. The bar is green if the risk is lower and red if it is higher than average. Then the physician should discuss preventive lifestyle interventions.

Professor Miia Kivipelto who has done the research (1,2) on which the App is based says: "The biggest risk factor for developing dementia is advanced age. Large epidemiological studies have demonstrated that what is good for the heart is good for the brain - in other words, a healthy lifestyle with physical activity, low blood cholesterol levels, not being obese, and having normal blood pressure at midlife protects not only against cardiac disease, but also against dementia."

More information about Merz on http://www.merz.com.

  1. Kivipelto M et al.; Lancet Neurol 2006;5:735-41
  2. Sindi et al. Poster presented at the 13th Geneva /Springfield Symposium, March 2014

Pressekontakt:
Merz Pharmaceuticals GmbH
Dr. Elisabeth Calov
Tel: +49-(0)69-1503-8428
E-mail: elisabeth.calov@merz.de

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CPhI & P-MEC China 2014 Event Achieved its Grand Closing

Leading Global Industry Trends, Lighting up the China Pharmaceutical Dream SHANGHAI, Aug. 26, 2014 /PRNewswire/ -- CPhI, ICSE & BioPh China 2014 and P-MEC, InnoPack...

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ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection

LONDON, Aug. 23, 2014 /PRNewswire/ -- ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.1 Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the HLA-B*5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin. Products containing abacavir should not be used in patients known to carry the HLA-B*5701 allele.1

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare, said: "Today's approval of Triumeq offers many people living with HIV in the US the first single-pill regimen containing dolutegravir. ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines."

This FDA approval is based primarily upon data from two clinical trials:

  • the Phase III study (SINGLE) of treatment-naive adults, conducted with dolutegravir and abacavir/lamivudine as separate pills2,3
  • a bioequivalence study of the fixed-dose combination of abacavir, dolutegravir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.4

In the SINGLE study, a non-inferiority trial with a pre-specified superiority analysis, more patients were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamivudine arm (the separate components of Triumeq) than in the Atripla®+ (efavirenz, emtricitabine and tenofovir) arm, the most commonly used single-pill regimen. The difference was statistically significant and met the pre-specified test for superiority. The difference was driven by a higher rate of discontinuation due to adverse events in the Atripla arm.2, 3

  • At 96 weeks, 80% of participants on the dolutegravir-based regimen were virologically suppressed compared to 72% of participants on Atripla. Grade 2-4 treatment emergent adverse reactions occurring in 2% or more participants taking the dolutegavir-based regimen were insomnia (3%), headache (2%) and fatigue (2%).3

About HIV

HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life.5-7

HIV infects specific cells of the immune system, called CD4 cells or T-cells. Over time, HIV can destroy so many of these cells that the body cannot fight off infections and disease. When this happens, HIV infection leads to Acquired Immunodeficiency Syndrome (AIDS) which is the final stage of HIV infection. There is no cure for HIV, but with early diagnosis and effective treatment most people with HIV will not go on to develop AIDS.5-7

An estimated 1.1 million people in the US are living with HIV. However, only 33 per cent are taking the medication they need.8

About Triumeq

Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine.

Two essential steps in the HIV life cycle are replication -- when the virus turns its RNA copy into DNA -- and integration -- the moment when viral DNA becomes part of the host cell's DNA. These processes require two enzymes called reverse transcriptase and integrase. NRTIs and INSTIs interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells.

Dolutegravir was approved in the US in August 2013 and in Europe in January 2014 under the brand name Tivicay®. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion on the Marketing Authorisation Application (MAA) for Triumeq on 26 June 2014. Regulatory applications are also being evaluated in other markets worldwide, including Australia, Brazil and Canada.

Tivicay and Triumeq are registered trademarks of the ViiV Healthcare group of companies.

Important Safety Information (ISI) for Triumeq (abacavir, dolutegravir and lamivudine) tablets

The following ISI is based on the Highlights section of the Prescribing Information for Triumeq. Please consult the full Prescribing Information for all the labeled safety information for Triumeq.

BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS B

See full Prescribing Information for complete boxed warning.

  • Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir-containing products.
  • Hypersensitivity to abacavir is a multi-organ clinical syndrome.
  • Patients who carry the HLA‑B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir.
  • Discontinue Triumeq as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue Triumeq if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
  • Following a hypersensitivity reaction to abacavir, NEVER restart Triumeq or any other abacavir‑containing product.
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
  • Severe acute exacerbations of hepatitis B have been reported in patients who are co‑infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV-1) and have discontinued lamivudine, a component of Triumeq. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.

CONTRAINDICATIONS

  • Presence of HLA-B*5701 allele.
  • Previous hypersensitivity reaction to abacavir, dolutegravir or lamivudine.
  • Co-administration with dofetilide.
  • Moderate or severe hepatic impairment.

WARNINGS AND PRECAUTIONS

  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of Triumeq. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with Triumeq is recommended in patients with underlying hepatic disease such as hepatitis B or C.
  • Hepatic decompensation, some fatal, has occurred in HIV-1/Hepatitis C Virus (HCV) co‑infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue Triumeq as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
  • Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy.
  • Administration of Triumeq is not recommended in patients receiving other products containing abacavir or lamivudine.

ADVERSE REACTIONS

The most commonly reported (greater than or equal to 2%) adverse reactions of at least moderate intensity in treatment-naive adult subjects receiving Triumeq were insomnia (3%), headache (2%), and fatigue (2%).

DRUG INTERACTIONS

Co-administration of Triumeq with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of Triumeq. The potential drug-drug interactions must be considered prior to and during therapy.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Triumeq should be used during pregnancy only if the potential benefit justifies the potential risk.
  • Nursing mothers: Breastfeeding is not recommended due to the potential for HIV transmission.
  • Triumeq is not recommended in patients with creatinine clearance less than 50 mL per min.
  • If a dose reduction of abacavir, a component of Triumeq, is required for patients with mild hepatic impairment, then the individual components should be used.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

References:

  1. Triumeq US label
  2. Walmsley SL, Antela A, Clumeck N et al; for the SINGLE Investigators. Dolutegravir plus abacavir–lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807-1818.
  3. Walmsley S, Berenguer J, Khuong-Josses M, et al. Dolutegravir regimen statistically superior to efavirenz/tenofovir/emtricitabine: 96-week results from the SINGLE study (ING114467). Poster presented at: 21st Conference on Retroviruses and Opportunistic Infections; March 3-6, 2014; Boston, MA. Poster 543.
  4. Weller S, Chen S, Borland J et al. Bioequivalence of a Dolutegravir, Abacavir and Lamivudine Fixed-Dose Combination Tablet and the Effect of Food. JAIDS. 2014 May doi: 10.1097/QAI.0000000000000193.http://journals.lww.com/jaids/Abstract/publishahead/Bioequivalence_of_a_Dolutegravir,_Abacavir_and.97920.aspx.
  5. Centers for Disease Control and Prevention. HIV Basics. http://www.cdc.gov/hiv/basics/index.html. Accessed July 28, 2014.
  6. NHS Choices, HIV & AIDS Overview. http://www.nhs.uk/conditions/HIV/Pages/Introduction.aspx. Accessed July 28, 2014.
  7. Centers for Disease Control and Prevention. CDC Fact Sheet. HIV in the United States: The Stages of Care. http://www.cdc.gov/hiv/pdf/research_mmp_StagesofCare.pdf. Accessed July 28, 2014.
  8. Centers for Disease Control and Prevention. Today's HIV/AIDS Epidemic. http://www.cdc.gov/nchhstp/newsroom/docs/HIVFactSheets/TodaysEpidemic-508.pdf. Accessed July 28, 2014.

+Atripla is a registered trademark of Bristol-Meyers Squibb and Gilead Sciences, LLC.

ViiV UK/US Media enquiries:

Sebastien Desprez

Marc Meachem

+44 7920 567 707

+1 919 483 8756

GSK Global Media enquiries:

David Daley

Melinda Stubbee

+44 20 8047 5502

+1 919 483 2510

GSK Analyst/Investor enquiries:

Ziba Shamsi

Kirsty Collins (SRI & CG)

Tom Curry

Gary Davies

James Dodwell

Jeff McLaughlin

Lucy Singah

+44 20 8047 5543

+44 20 8047 5534

+1 215 751 5419

+44 20 8047 5503

+44 20 8047 2406

+1 215 751 7002

+44 20 8047 2248

GlaxoSmithKline cautionary statement regarding forward-looking statements: GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under Item 3.D "Risk factors" in the company's Annual Report on Form 20-F for 2013.


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Amerigen Pharmaceuticals Ltd. Announces that its Chinese Subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has Received Chinese FDA (CFDA) Approval and has Subsequently Launched its Generic Mecobalamin 0.5 mg Tablets into the China Domestic Market

LYNDHURST, N.J., Aug. 20, 2014 /PRNewswire/ -- Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China domestic market. Under the terms of a marketing and distribution agreement with Sinochem Jiangsu Pharmaceutical Co., Ltd., Amerigen is manufacturing the product at its US FDA approved and China CFDA certified oral solid dose facility in Suzhou, China. Sinochem is distributing the product under the Suzhou Amerigen label with exclusive sales rights in the People's Republic of China.

John Lowry, Amerigen's President & CEO, commented, "The approval and launch of Mecobalamin is Amerigen's first generic product entry in China and we are very pleased to have Sinochem, a leading and highly reputable player in the Chinese pharmaceutical industry, participate in this important milestone as our sales and distribution partner. We expect additional near term product approvals in China as we continue to bring high quality, locally manufactured generic products to the rapidly growing Chinese market."

Mr. Ziqiang Wu, General Manager of Sinochem Pharma, stated, "Sinochem is pleased to see that the Mecobalamin Tablet product produced by Suzhou Amerigen Pharmaceuticals Co. Ltd. has been approved by CFDA, which embodies a solid step towards the business cooperation on generic drugs in the Chinese market. We also expect to deepen the cooperation with Amerigen and expand more high-quality drugs into this fast-growing drug market."

About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Limited, is located in Suzhou, Jiangsu Province. The group has an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

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Coherus Announces CHS-1420 (Investigational Adalimumab Biosimilar) Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study

-- Company To Pursue Next Stage of Development

REDWOOD CITY, California, Aug. 15, 2014  /PRNewswire/ -- Coherus BioSciences, Inc. ("Coherus") today announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira® in healthy subjects. The parallel-group, single-dose study met the criteria for clinical PK similarity on all three required, prospectively defined, PK endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC0-t), and area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), with all three geometric mean ratios fully within the 90% confidence interval from 80% to 125%. Both agents were well tolerated and there were no differential safety findings observed between the two agents in this study.

Logo - http://photos.prnewswire.com/prnh/20120507/SF01448LOGO

"An essential global regulatory requirement is the completion of a clinical study directly comparing the originator and our biosimilar candidate establishing PK similarity," said Barbara Finck, M.D., Chief Medical Officer of Coherus. "We are pleased to have achieved robust results which we believe represents a significant reduction in development program risk."

"Adalimumab is a very complex molecule. Achieving this clinical milestone further validates Coherus' development platform and demonstrates our ability to advance biosimilars across our portfolio," said Denny Lanfear, President and Chief Executive Officer of Coherus.

About Coherus BioSciences, Inc.
Coherus is a late-stage clinical biologics platform company focused on the global biosimilar market. Headquartered in the San Francisco Bay Area and composed of a team of industry veterans with decades of experience in pioneering biologics companies, our goal is to become a global leader in the biosimilar market by leveraging our team's collective expertise in key areas such as process science, analytical characterization, protein production and clinical-regulatory development. Coherus' commercialization partnerships include global pharmaceutical companies in Europe, Asia and Latin America.

Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. For additional information, please visit www.coherus.com.

Coherus BioSciences Contact
Beth Jimison
+1-650-649-3526
bjimison@coherus.com

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Frost & Sullivan Honors Vitro Biopharma for its Outstanding Technological Innovations and Business Strategy in the Stem Cell Tools Industry

--The company aims to increase the market penetration of its proprietary MSC-based research products, while expanding its stem cell segment to include differentiated cells derived from MSCs

MOUNTAIN VIEW, Calif., Aug. 5, 2014 /PRNewswire/ -- Based on its recent analysis of the stem cell tools and technologies industry, Frost & Sullivan recognizes Vitro Biopharma with the 2014 North American Frost & Sullivan Award for Technology Innovation Leadership. Vitro Biopharma has excelled in the development of tools and technologies to support stem cell research and clinical studies of mesenchymal stem cells (MSCs). The company offers different cell culture media for the maintenance and differentiation of growing MSCs, while simultaneously expanding its product line to include measurement tools and technologies that determine the potency, quality, response, and behavior of MSCs.

Vitro Biopharma produces not only native MSC lines, but also fluorescent-labeled MSC lines that can be utilized in tracking studies and in vivo live cell imaging. The company, in partnership with Hemogenix, Inc., has developed a proprietary read-out system for accurate measurement of cellular ATP content to test cellular functionality. Based on the HALO® assay platform for high-sensitivity analysis of hematopoietic stem cells (HSCs), this technology is one of the most sensitive bioluminescent read-out assays and includes fluorescent and absorbance-based cellular functionality analyses.

Vitro Biopharma has developed a proprietary MSC line culture media, MSC-Gro™, which has been optimized to support growth and differentiation of MSC lines. The major competitive advantages of this media over its peers are increased rate of growth and superior quality and potency of the MSC lines. Studies have shown that yields reach two to three times the number of cells when utilizing MSC-Gro media culture. Moreover, MSC-Gro media formulations can be stored for more than a year at 2 degrees Celsius to 8 degrees Celsius without alterations.

"Diversity is the other important advantage of Vitro's technology. The media allows the user to prepare additional formulations according to the requirements of various primary cells, such as neurons, hepatocytes, and fibroblasts," said Frost & Sullivan Industry Analyst Cecilia Van Cauwenberghe. "The level of serum in the media (serum-containing or serum-free) enables customers to design a broader spectrum of applications. In fact, customers can select the media that suits each application, under liquid or powder formulations."

Beyond commercial products based on stem cell life sciences tools and technologies, Vitro Biopharma is pursuing white space innovation through its proprietary intellectual property tuned to specific inventions and medical applications. It entered into a license agreement for intellectual rights to the production and purification of the pituitary hormone, FSH, to be used in fertility treatments. Similarly, it licensed the rights for the use of a stem cell line for the treatment of infertility. The company is advancing toward the design of a new cell reprogramming technique, with a pending patent application related to novel methods for generation of induced PSCs (iPSCs) from adult stem cells (ASCs).

Currently, Vitro Biopharma is commercializing a series of stem cell-based assays for osteoporosis drug discovery and discovery of stem cell activation agents through assays of ASC proliferation, migration and reprogramming. Among its most relevant services is the customized biomarker panel analysis to quantify the levels of multiple biological molecules in biological samples. Indeed, under its new business perspective, the assay of human serum samples collected from patients from multiple European clinical treatment centers could make the company a leading provider of serial bio-analytical tools and technologies, not only in North America, but also in Central Europe.

Vitro Biopharma is also working on accelerating healing of bone fractures using MSCs and strengthening bones by activating certain protein signals and molecules. Although optimal signaling of pathways to activate MSCs with the goal of repairing or regenerating bone tissue is still under development, preliminary studies demonstrate significant potential for the creation of new drugs to treat osteoporosis. In fact, the company recently launched its initial line of osteoblasts derived from human MSCs for use in drug discovery and development.

Meanwhile, Vitro Biopharma is aligning its scheduled stages of clinical trials to test mobilization of endogenous stem cells in the treatment of traumatic brain injury and autism spectrum disorders (ASD). For this condition, pre-clinical research strongly suggests that activation of certain biochemical pathways increases stem cell proliferation, migration, and regenerative performance. Vitro Biopharma's approach eliminates stem cell transplantation, while providing a non-controversial, cost- and time-effective alternative to the current methodologies of competitors.

"Vitro Biopharma's technology platform allows generation of iPSCs from ASCs, including MSCs and other subclasses, avoiding the utilization of transfection mechanisms through environmental conditions and small molecules to induce the expression of some reprogramming factors through promoter activation," noted Van Cauwenberghe. "The utilization of ASCs, including MSCs, represents a powerful, efficient, and safe alternative to ESCs derived from embryos."

Vitro Biopharma's business strategy involves the participation of biopharmaceutical firms, large distributors, and contract research organizations (CROs). One of the most successful decisions of Vitro Biopharma has been its merger with Neuromics Inc. to accelerate growth in the near term. The former's research products are primarily focused on ASCs and derivative products, while the latter's product lines include antibodies and biomarkers, as well as an impressive number of products for proteomics and genomics, apoptosis assays, molecular biology reagents, and complementary assays products.

This partnership has enabled Vitro Biopharma to focus on the development of its own pipeline of drug discovery and development products including stem cell-based assays. Vitro Biopharma's innovative business model facilitates the establishment of diversified sources and well-implemented sales strategies to penetrate research and clinical development markets with its unique stem cell-based technology platform.

Each year, Frost & Sullivan presents this award to the company that demonstrates uniqueness in developing and leveraging new technologies, which significantly impacts both the functionality and the customer value of the new products and applications. The award lauds the high R&D spend toward innovation, its relevance to the industry and the positive impact on brand perception.

Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for outstanding achievement in areas such as leadership, technological innovation, customer service, and product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research.

About Vitro Biopharma

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG; http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes.  In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells "Tools for Stem Cell and Drug Development™," including human mesenchymal stem cells and derivatives, the MSC-Gro™ Brand of optimized media for MSC self-renewal and lineage-specific differentiation. In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships, including an alliance with Neuromics, Inc. (www.neuromics.com). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well-established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems. We jointly manufacture stem cell assay systems with HemoGenix®, Inc. (http://www.hemogenix.com/), known as the MSCglo quantitative assay for determination of MSC quality, potency and response to toxic agents. Also, Vitro Biopharma's CEO is a consultant on an NSF grant at the City College of New York to advise Dr. Lane Gilcrest, professor of Materials Science and Engineering, and his colleagues regarding the development of novel extracellular materials for use in self-renewal and differentiation of mesenchymal stem cells.

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Contact:

Mireya Espinoza
P: +1-210-247-3870
F: +1-210-348-1003
E: mireya.espinoza@frost.com

Media Contact for Vitro Biopharma:

Dr. Jim Musick
P: +1-303-999-2130
F: +1-303-762-1240
E: jim@vitrobiopharma.com

 

 

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