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28.10.2014 05:39:55

AEZS To Watch Out, RCPT Surges In Afterhours, CEMI Focuses On Ebola, PTIE Hurt

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) announced Monday that the field selling of ASCEND Therapeutics US LLC's EstroGel in specific U.S. territories is scheduled to start in the week of November 17, 2014.

Aeterna Zentaris and ASCEND signed a co-promotion Agreement for the U.S. market in August of this year.

Under the terms of the deal, Aeterna Zentaris agreed to use its sales force to market, in specific U.S. territories, ASCEND's FDA-approved EstroGel, while ASCEND agreed to market, in specific U.S. territories, Macrilen, Aeterna Zentaris' product.

Aeterna Zentaris' Macrilen for use in the evaluation of adult growth-hormone deficiency is under FDA review, with a decision date set for November 5, 2014.

AEZS closed Monday's trading at $1.22, up 4.27%.

Chembio Diagnostics Inc. (CEMI) gained over 18 percent on Monday after it announced that it has entered into an exclusive agreement with privately held Integrated BioTherapeutics Inc. to develop point-of-care diagnostic tests for Ebola and Febrile illness.

Financial terms of the agreement were not disclosed.

CEMI touched a new 52-week high of $5.20 on Monday before closing at $4.73.

Heat Biologics Inc. (HTBX) has initiated patient dosing in its phase II clinical trial of vesigenurtacel-L (HS-410) in subjects with high-risk, non-muscle invasive bladder cancer.

The study, designed to enroll approximately 75 patients, is expected to complete enrollment in the third quarter of 2015 and report top line results in third quarter of 2016. The primary endpoint for the trial is one-year disease-free survival.

HTBX closed Monday's trading at $6.58, up 4.44%.

Shares of The Medicines Co. (MDCO) rose more than 13 percent in extended trading Monday, following a favorable judgment in a patent litigation related to its anticoagulant Angiomax.

The Medicines Co. filed a patent infringement suit against Mylan Inc. (MYL) in February 2011 in an Illinois federal court seeking to block Mylan's planned generic version of Angiomax. The patents covering Angiomax are said to expire in 2028. In Europe, the drug is marketed under the trade name Angiox. The global Angiomax/Angiox revenue in 2013 was $608.6 million, up from $548.2 million in 2012.

The ruling delivered by the Illinois Court prevents Mylan from obtaining FDA approval for its generic Angiomax and launching it until the earlier of a successful appeal or patent expiry of the drug in 2028.

MDCO closed Monday's trading at $22.19, up 1.14%. In after-hours, the stock gained 13.79% to $25.25.

Shares of Pain Therapeutics Inc. (PTIE) and DURECT Corp. (DRRX) plummeted on Monday as Pfizer decided to discontinue its agreement to develop and commercialize REMOXY (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone.

DURECT licensed Remoxy to Pain Therapeutics in December 2002, which subsequently sublicensed it to King Pharmaceuticals in 2005. King was acquired by Pfizer in February 2011.

Now that Pfizer has discontinued the agreement, Pain Therapeutics has the rights to develop and commercialize REMOXY on its own or with an alternative licensee.

PTIE fell 53.01% on Monday to close at $1.95. DRRX closed Monday's trading at $0.76, down 45.32%.

Shares of Receptos Inc. (RCPT) rose more than 30 percent in after-hours Monday, following positive results from a phase II trial of its experimental drug RPC1063 in ulcerative colitis.

In the trial, dubbed TOUCHSTONE, 16.4% of patients on 1 mg dose of RPC1063 achieved clinical remission compared to 6.2% of patients on placebo at week 8, which was statistically significant.

RPC1063 has also demonstrated its efficacy and safety in a phase II trial in relapsing multiple sclerosis. The results of the trial were announced in June of this year.

RCPT closed Monday's trading at $67.74, up 0.50%. In after-hours, the stock was up 30.65% at $88.50.

Vitae Pharmaceuticals Inc. (VTAE) soared more than 50 percent on Monday following exercise of underwriters' option to purchase additional shares of initial public offering.

The company went public on the NASDAQ Global Market as recently as September 24, 2014, offering its shares at a price of $8 each.

Vitae Pharma's most advanced product candidate is VTP-34072 for the treatment of type 2 diabetes and metabolic syndrome. A phase II trial of VTP-34072 was started in July 2014, with data from this trial expected in the first half of 2015.

Last week, the company announced positive top-line results from two phase I trials of BI1181181/VTP-37948 - the company's Alzheimer's disease drug candidate - in healthy volunteers.

VTAE closed Monday's trading at $13.70, up 50.38%.

Wright Medical Group Inc. (WMGI) and Tornier N.V. (TRNX) are all set to merge in an all stock transaction with a combined equity value of approximately $3.3 billion. Upon completion of the merger, Wright shareholders will own approximately 52% of the shares of the combined company on a fully diluted basis and Tornier shareholders will own approximately 48%.

The transaction is expected to close in the first half of 2015.

Meanwhile, Wright has received an Approvable Letter from the FDA for its Premarket Approval Application for Augment Bone Graft. The approvable letter indicates that FDA determined Augment Bone Graft to be safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications and is approvable subject to customary preapproval facilities inspections.

TRNX closed Monday's trading 1.95% higher at $24.05. In after-hours, the stock was up 25.41% at $30.16.

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