Avanir Announces Diabetes Co-Promotion Agreement with Merck; Celldex Announces Expansion of Phase 2 ReACT Study Print E-mail
By Staff and Wire Reports   
Monday, 12 August 2013 19:37

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 12, 2013.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that it has entered into an exclusive, multi-year agreement with Merck (NYSE: MRK), known as MSD outside the United States and Canada, to co-promote Merck's type 2 diabetes therapies JANUVIA® (sitagliptin) and the sitagliptin family of products in the long-term care institutional setting in the United States.

"As a company dedicated to the advancement of diabetes care, we are excited to partner with Avanir to help improve diabetes management and offer our type 2 diabetes therapies to this patient population," said Peter Alberti, U.S. marketing leader, Diabetes, Merck. "We believe that combining Merck's leadership in diabetes with Avanir's unique capabilities will help this growing population get the diabetes care they need."

Avanir's institutional sales force will promote the sitagliptin family of products to health care practitioners in the long-term care institutional setting beginning in October 2013. Under the terms of this agreement, Avanir will be compensated via a fixed fee plus an incentive-based payment. Merck will continue to remain responsible for the promotion of the sitagliptin family of products in all other settings and will remain responsible for all other aspects of research, manufacturing and marketing.

"We are extremely pleased to enter this agreement with Merck for its key diabetes therapies. This agreement will further advance our vision to become a leading specialty biopharmaceutical company and drive our commercial operations forward," said Rohan Palekar, chief commercial officer at Avanir. "Our sales force is well established within the institutional setting and should be able to expand the adoption of Merck's diabetes therapies based on their deep understanding of the treatment needs of these physician and patient populations."

About JANUVIA® (sitagliptin) 25 mg, 50 mg, and 100 mg tablets -- JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.


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Celldex Therapeutics, Inc. (Nasdaq: CLDX)
Celldex Therapeutics recently completed enrollment in an initial cohort (n=25) of Avastin® (bevacizumab) refractory patients in the Company's ongoing ReACT study of rindopepimut in EGFRvIII (v3)-positive glioblastoma (GBM). Based on early evidence of anti-tumor activity, including stable disease, tumor shrinkage and investigator-reported response, the Company has decided to add an expansion cohort of approximately 75 patients to better characterize the potential activity of rindopepimut in this refractory patient population. Enrollment in the expansion cohort has begun and, like the initial cohort, will evaluate rindopepimut plus Avastin.

"Patients with GBM who have become refractory to Avastin tend to have very rapid disease progression," said Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. "Based upon preliminary evidence that rindopepimut may have activity in Avastin refractory GBM, we have decided to expand the refractory group with the hope of better defining possible therapeutic effect. We expect to share a formal review of the results from the initial 25 patients at the Society for Neuro-Oncology Annual Meeting in November."   Avastin is a registered trademark of Genentech, a member of the Roche Group.


Also Monday:


Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, announced today that it has entered into an agreement with Eastern Capital Limited to amend the Company's Series B Preferred Stock Certificate of Designations, Preferences and Rights to, among other things, amend the treatment of the Company's Series B-1 Non-Voting Preferred Stock and Series B-2 Voting Preferred Stock.

Alimera Sciences, Inc. (NASDAQ: ALIM)
, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced financial results for the second quarter ended June 30, 2013.

Amgen (NASDAQ: AMGN)
and Servier today announced the early termination of the waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in connection with the cardiovascular product collaboration agreement announced on July 8, 2013, completing the transaction.

Aratana Therapeutics, Inc. (NASDAQ: PETX)
today announced its financial results for the second quarter of 2013, product development updates and the continued build-out of its pipeline.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, today announced that scientists at Newcastle University have been awarded £1 million (approximately $1.5 million) by the UK's Medical Research Council for a clinical trial to evaluate whether seliciclib, Cyclacel's oral cyclin dependent kinase (CDK) inhibitor currently in clinical development to treat certain cancers, can be repurposed to treat rheumatoid arthritis (RA) in patients who do not respond to existing treatments.

DelMar Pharmaceuticals, Inc. (OTCQB: DMPI)
announced that the company hosted a symposium entitled "VAL-083 for Newly Diagnosed GBM Patients with Unmethylated MGMT Promoter"at the 10th Annual Meeting of the Chinese Society for NeuroOncology (CSNO), in Kunming, China on August 10, 2013.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
announced today that the Board of Directors approved a quarterly dividend of 5.5 cents per common share on August 9, 2013.

Endo Health Solutions (Nasdaq: ENDP)
today announced that its wholly owned subsidiary, HealthTronics, Inc. has entered into a definitive agreement to sell its anatomical pathology business, HealthTronics Laboratory Solutions, Inc., ("HLS") to Metamark Genetics, Inc. ("Metamark") for an undisclosed amount.  

Generex Biotechnology Corporation (OTCBB:GNBT)
today provided call-in details for the previously announced conference call featuring members of the Antigen Express, Inc.

GeoVax Labs, Inc. (OTCQB: GOVX)
, a biotechnology company developing vaccines to prevent and treat HIV/AIDS, announced its financial results for the six months ended June 30, 2013 and provided a clinical development update.

Health Insurance Innovations, Inc. (Nasdaq:HIIQ)
, a leading developer and administrator of affordable, cloud-based individual health insurance plans and ancillary products, today announced the appointment of healthcare financial expert Paul Gabos to its Board of Directors.

MediSwipe Inc. (OTCQB: MWIP)
, a patient security solutions and software development company for the medicinal marijuana and health care industry, and 800 Commerce Inc., an innovative online directory and mobile marketing company, today announced that its Registration Statement on Form S-1/A has been declared effective by the U.S. Securities & Exchange Commission (the "SEC") as of August 9, 2013.

MMRGlobal, Inc. (OTCQB: MMRF)
today announced it plans to file its quarterly report on Form 10-Q for the period ended June 30, 2013 on Wednesday, August 14, 2013.

MRI Interventions, Inc. (OTCQB: MRIC)
today announced treatment of the first patient in a Phase I clinical trial utilizing uniQure B.V.'s glial cell line-derived neurotrophic factor (GDNF) for treatment of Parkinson's disease.

Nano Labs Corp. (OTCQB:CTLE)
is pleased to announce today the Company has signed a Non-Disclosure Agreement (NDA) with GMI of Mexico.

OPTIMIZERx Corp. (OTCQB: OPRX)
will be holding its Q-2 earnings call on Wednesday August 14th at 12:00 PM Eastern Standard Time.

Organovo Holdings, Inc. (NYSE MKT: ONVO)
a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, has reported on its financial results for the three-month period ended June 30, 2013 and provides a business update.

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery and development of novel antibodies for the potential treatment of a broad range of diseases, today reported financial results for the second quarter and six months ended June 30, 2013 and provided an update on research and development.

PTC Therapeutics, Inc. (NASDAQ: PTCT)
, a biopharmaceutical company focused on the discovery and development of orally administered, proprietary small-molecule drugs that target post-transcriptional control processes, today announced financial and corporate results for the quarter ended June 30, 2013.

Rockwell Medical, Inc. (NASDAQ: RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it has been selected to participate in the ASN Innovators Place 2013, during the ASN Kidney Week 2013 Annual Meeting, November 7-10 in Atlanta, GA.

Vision-Sciences, Inc. (Nasdaq:VSCI)
today announced financial results for the first quarter of fiscal 2014, ended June 30, 2013.

WuXi PharmaTech (Cayman) Inc. (NYSE: WX)
, a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its unaudited financial results for the second quarter of 2013.




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