|Neuralstem gets FDA go ahead on trial. Impax sells rights to Glaxo for Parkinsons drug. After the bell: Nymox Pharma gets European partner|
|By Mary Davila|
|Thursday, 16 December 2010 19:35|
After the bell, shares of Nymox Pharmaceutical Corporation (Nasdaq:NYMX) were active as the company, along with Recordati (Milan:REC) announced today the signing of a European licensing agreement for the development and commercialization of NX-1207, Nymox's Phase III investigational drug currently in clinical development in the U.S. for the treatment of benign prostatic hyperplasia (BPH).
Under the terms of the agreement, Recordati receives exclusive rights to develop and subsequently market and sell NX-1207 in Europe including Russia and the CIS, the Middle East, the Maghreb area of North Africa and South Africa. The licensing agreement covers the use of NX-1207 for the treatment of BPH as the initial indication for development and commercialization. Recordati will make an upfront payment to Nymox of approximately $13 million US; approval and sales milestones payments; and tiered supply and royalty payments of a minimum of 26% to increase progressively up to 40% of total net sales in the case specific contractual conditions are achieved.
The stock closed the day at $4.46, in extended trading the last trade showed $7.49.
Prestige Brands Holdings, Inc. (NYSE:PBH), a leading marketer of branded consumer products, after the bell today announced that it has entered into a definitive agreement to acquire the assets associated with the Dramamine business in the U.S. from McNeil-PPC, Inc. for $76 million in cash.
International Stem Cell Corporation (OTCBB:ISCO.ob) announced today that it had launched the first phase of its previously announced joint marketing campaign with John Mauldin, the founder and Chairman of Millennium Wave Investments, to market Lifeline Skin Care’s (LSC) new topical skin care products to more than one million of Mauldin’s subscribers. This launch follows ISCO’s earlier successful release to its own investor base and to the general public through its website.
Mauldin, a best-selling writer, author of a monthly investment newsletter, and recognized marketing expert, provides LSC with the skills and a platform to enable LSC to continue expanding its sales while keeping marketing cost per customer lower than would be possible with a traditional media campaign.
Lifeline Skin Care’s exclusive patent pending skin rejuvenation serums contain extracts from ISCO’s proprietary "parthenogenetic" stem cells created from unfertilized eggs. The stem cell extract was discovered during ISCO’s therapeutic research that revealed the extract’s potential applications in skin cell rejuvenation. Independent third party testing indicates that both the day and the night serums now being offered have significant positive effects on the look and feel of the skin.
"Having seen a strong demand from our investors and followers, we have been working diligently to increase both our marketing and production capabilities. John Mauldin’s participation will support the continuation of our rapid progress," says Dr. Ruslan Semechkin, CEO of Lifeline Skin Care.
Shares of International Stem Cell jumped 25 cents or 14.58% to $1.92.
The FDA today approved Neuralstem, Inc's. (NYSE Amex: CUR) Investigational New Drug (IND) application to initiate a Phase Ia safety trial to test NSI-189, its first small molecule compound, in major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression and other diseases, such as Alzheimer's disease.
"Today's antidepressants are based on a theory of serotonin deficiency," explained Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "A new theory is emerging that chronic stress can lead to hippocampal atrophy and eventually to depression. NSI-189 appears to help the brain repair itself, generating new neurons and protecting against damage. This neurogenic approach is completely novel in the treatment of CNS diseases."
Shares of Neuralstem gained 14 cents or 6.45%. Nearly 1 million shares exchanged hands.
Shares of Impax Laboratories (Nasdaq:IPXL) increased on heavy volume today after it was reported that GlaxoSmithKline (NYSE:GSK) had acquired the rights outside of the U.S. to an extended Parkinson's disease drug. The drug, known as IPX066, is a combination of carbidopa and levodopa. The deal is worth up to $186.5 million for Impax which includes an $11.5 million up front payment from Glaxo and, depending on success, milestones of up to $175 million. Impax will also make and supply the drug to Glaxo as well as receive double digit royalties on sales. Impax expects to file for U.S approval in late 2011.
On heavy volume, shares of Impax jumped $1.09 or 5.56% to $20.68.
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, presented new data at the 2010 International Chemical Congress of Pacific Basin Societies (Pacifichem), being held in Honolulu, Hawaii, December 15-20. New data show recent progress in the company’s delivery efforts with siRNAs as well as results related to the translation of RNAi therapeutics in human clinical studies, specifically with the company’s ALN-VSP liver cancer program.
Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported the completion of patient randomization for its ANCHOR trial, a pivotal Phase 3 trial of AMR101. The Company indicated that it anticipates reporting top-line results from this trial in Q2 2011. The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels from 200 mg/dL to less than 500 mg/dL who are also on statin therapy.
Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that the Company has been awarded Phase I of a Fast Track Small Business Innovation Research Grant (SBIR) from the National Institutes of Health (NIH) to support the development of the Company's program for aerosolizing KL4 surfactant for neonatal respiratory distress syndrome (RDS). The Company submitted a proposal, with a total budget of $2.4 million, for the development of the Company's proprietary capillary aerosol generating (CAG) device technology followed by a Phase 2a clinical trial of aerosolized KL4 surfactant in preterm infants with or at risk for RDS. The Phase I grant provides $580,000 to support development efforts. The Company anticipates the potential awarding of the Phase II grant, up to an additional $1.8 million, following the conclusion of Phase I activities.
Manhattan Pharmaceuticals, Inc. (OTCBB:MHAN) announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.
Novavax, Inc. (Nasdaq:NVAX) announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.
Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced that it has provided notice of voluntary prepayment of its senior secured loan facility to GE Business Financial Services Inc. and Silicon Valley Bank. The Company expects to pay the approximately $12.3 million balance on the facility, including interest and other fees payable under the loan agreement, prior to year-end. Once repaid, all covenants and restrictions related to the facility will lift, including lender consent requirements restricting certain asset sales, mergers and acquisition transactions and financial covenants requiring the Company to maintain a minimum amount of unrestricted cash. Assisted Living Concepts, Inc. (NYSE: ALC) announced that, after prior discussions, Eric B. Fonstad, Senior Vice President, General Counsel and Secretary of Assisted Living Concepts, Inc., confirmed that he intends to retire on December 31, 2010.