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MAPP Bought Out, TELK Rises, TSOI, AMPE Begin Anew, EDAP On High, CLSN Heats Up


MAP Pharmaceuticals Inc. (MAPP) has agreed to be acquired by Allergan Inc. (AGN) for approximately $958 million or $25.00 per share. MAP Pharma's LEVADEX, an orally inhaled drug for the potential acute treatment of migraine in adults, is currently under FDA review with a decision expected on April 15, 2013.

Celgene International Sàrl, a subsidiary of Celgene Corp. (CELG), announced Tuesday that its cancer drug Abraxane in combination with chemotherapy drug Gemcitabine demonstrated a statistically significant improvement in overall survival (8.5 months) compared to patients receiving Gemcitabine alone (6.7 months) in a phase III study of patients with advanced pancreatic cancer.

Abraxane is approved to treat breast cancer and non-small cell lung cancer. It is not currently approved for the treatment of advanced pancreatic cancer.

Telik Inc. (TELK) shares rose over 15% in extended trading on Tuesday after the company announced it has reached a preliminary agreement on design of phase III registration trial of Telintra in Low to Intermediate-1 risk myelodysplastic syndrome, or MDS.

Telintra is an investigational agent in development for the treatment of MDS and idiopathic chronic neutropenia. The compound has been granted orphan drug designation by the FDA for the treatment of MDS.

BioSante Pharmaceuticals Inc. (BPAX) and ANI Pharmaceuticals Inc. will hold a special meeting of their stockholders on Friday, March 15, 2013 to consider their proposed merger.

BioSante also announced that its board of directors has set the close of business on March 15, 2013, as the record date with respect to the anticipated distribution of contingent value rights, or CVRs.

Nymox Pharmaceutical Corp. (NYMX) on Tuesday announced new positive phase III safety and efficacy data of its investigational drug for prostate enlargement NX-1207.

In the study, which involved 192 patients, the mean duration from the initial injection to the final assessment was 26 months. According to the company, the mean overall improvement in the 192 treated men was 7.6 points as measured by the American Urological Association BPH Symptom Index Score.

Innovus Pharmaceuticals Inc. (INNV) on Tuesday appointed Bassam Damaj to serve as President & CEO, and a member of the Board of Directors, effective immediately. Damaj replaces Vivian Liu, who resigned from the company's management team. The company will also move its corporate headquarters from Sierra Madre, California to San Diego, California.

In a move that will enhance its portfolio with next-generation portable infusion pump technology, Hospira Inc. (HSP) has signed a distribution agreement with Q Core Medical Ltd., for the Q Core Sapphire multi-therapy infusion system. Financial details of the agreement were not disclosed.

Vitro Diagnostics Inc. (VODG), dba Vitro Biopharma, on Tuesday announced the launch of new stem cell products to accelerate bone growth.

Quest PharmaTech (QPT.V) announced Tuesday that it has enrolled the 40th patient in its ongoing 80 patient phase II Oregovomab front-line chemo-immunotherapy clinical trial for ovarian cancer in Italy and the U.S.

Therapeutic Solutions International Inc. (TSOI) announced Tuesday that it has shed its royalty obligation to Boyd Research Inc., marking the start of a new chapter in the company's life. Shares closed Tuesday's trading over 58% higher at $0.02.

The company has also reduced its total number of outstanding shares from 305.5 million to approximately 81.5 million by reacquiring 223,991,933 shares of its common stock from Boyd and retiring the shares.

The Perrigo Co. (PRGO) Tuesday announced that it has begun shipments of over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor). The launch represents the first to market nicotine mini lozenge products for the store brand market.

Anika Therapeutics Inc. (ANIK) announced that effective April 1, 2013, Sylvia Cheung will take over as the company's CFO, succeeding Kevin Quinlan. Cheung has served as Anika's Vice President for Strategic Processes since February 2012.

AVEO Pharmaceuticals Inc. (AVEO) on Tuesday announced that the underwriters of its recent public offering of common stock have exercised their option to purchase an additional 1 million shares at the public offering price of $7.50 per share. The company expects to issue a total of 7,667,050 shares upon the closing of the offering and to receive aggregate net proceeds, after underwriting discounts and commissions and other estimated offering expenses, of approximately $53.8 million. The offering is expected to close on or about January 23, 2013.

Celsion Corp. (CLSN) rose over 10% to close Tuesday's trading at $7.74 following its technology development agreement for ThermoDox with Zhejiang Hisun Pharmaceutical Co. Ltd., a Chinese pharmaceutical company. Celsion expects results from its pivotal phase III trial of ThermoDox in hepatocellular carcinoma, also known as primary liver cancer, later this month.

Theravance Inc. (THRX) on Tuesday announced that the underwriters of its 2.125% convertible subordinated notes due 2023 have exercised in full their option to purchase an additional $37.5 million aggregate principal amount of the notes, for a total offering size of $287.5 million. The offering is scheduled to close on Thursday, January 24, 2013.

EDAP TMS SA (EDAP) touched a new 52-week high of $3.05 on Tuesday before closing at $2.82. Driven by the strong sales trend across its lithotripsy business fueled by the continued demand for its innovative Sonolith i-move lithotripter, the company expects Q4, 2012 revenue of EUR 9.4 million (USD 12.2 million), a 25% year-over-year increase.

PURE Bioscience Inc. (PURE) on Tuesday launched its Hard Surface disinfectant and food contact surface sanitizer to corporate and government customers through Office Depot's Business Solutions Division. The new product offering is part of a current flu season marketing campaign as well as an ongoing sales program targeting corporate and government breakrooms.

Rexahn Pharmaceuticals Inc. (RNN) on Tuesday appointed Peter Suzdak as its new CEO. He succeeds Chang Ahn, who will move into the role of Chief Scientist and will remain as Chairman of the Board.

NeoStem Inc. (NBS) announced Tuesday that the intellectual property protection around its lead product candidate, AMR-001 under phase II trial in preserving heart function after a heart attack, has been expanded. This is the third U.S. granted patent for AMR-001.

Conceptus Inc. (CPTS) announced Tuesday that it has appointed operations executive Joseph Sharpe to the newly-created position of Executive Vice President of Operations, effective immediately.

Seeking to expand its oncology-focused pipeline, Progenics Pharmaceuticals Inc. (PGNX) on Tuesday acquired Molecular Insight Pharmaceuticals Inc., a clinical-stage private biotechnology company with a small molecule chemistry pipeline aimed at enhancing cancer treatment.

BioDelivery Sciences International Inc. (BDSI) has completed its study evaluating the safety and tolerability of BEMA Buprenorphine/Naloxone in the treatment of opioid dependent patients. The results of the study will enable the submission of a New Drug Application for BNX to the FDA in mid-2013. The company expects to hold a pre-NDA meeting with the FDA in the next few months.

Omeros Corp. (OMER) Tuesday reported positive safety data from a second phase III trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery. The co-primary efficacy endpoints of this trial were announced last November, which demonstrated that there was statistically significant maintenance of intraoperative mydriasis (pupil dilation) and statistically significant reduction of pain in the early postoperative period with OMS302.

Ampio Pharmaceuticals Inc. (AMPE) announced Tuesday it plans to commence enrollment in a clinical trial to evaluate Optina for the treatment of diabetic macular edema. The FDA granted Optina 505(b)(2) status in July, 2012. Drugs designated under this pathway can be approved based on a single trial.

by RTTNews Staff Writer

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