Curis, Inc. (NASDAQ: CRIS), saw its shares rise today as the company announced that its licensee Debiopharm S.A. has received approval from France's regulatory authority Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8 million milestone payment from Debiopharm for the achievement of this development objective.
"We believe that Debio 0932 may have broad potential in a number of cancer indications based on its multiple mechanisms of action and client proteins, and its remarkable pharmacological properties, and we are pleased that the second compound generated from Curis’ proprietary targeted cancer platform has advanced into the clinic," said Dan Passeri, Curis’ President and Chief Executive. "The acceptance by the French regulatory authorities of Debiopharm’s CTA package is an important milestone in the development of this innovative cancer treatment and a testimony to Debiopharm’s regulatory expertise and commitment to Debio 0932."
"We are excited that Debio 0932 has reached this important milestone and that the clinical studies will start. Debiopharm is committed to the development of this compound and we believe that Debio 0932 can address a major unmet medical need and become an important tool available for the treatment of cancer," said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group™.
Debiopharm plans to open a Phase I clinical trial evaluating the safety of Debio 0932 during the first quarter of 2010. The study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of multiple doses of Debio 0932 in patients suffering from advanced solid tumors or lymphoma.
Based on Curis’ research to date, the company believes that Debio 0932 may provide key benefits over Hsp90 inhibitors currently in clinical testing. Curis has evaluated the potency, safety, efficacy and pharmacological properties of Debio 0932 in multiple animal models, where it exhibits high oral bioavailability and selective retention in tumors, crosses the blood brain barrier and displays potent antitumor activity in several animal models when given alone or in combination with standard-of-care agents, while robustly inhibiting multiple signaling pathways, including PI3K/AKT and RAF/MEK/ERK.
"The $8 million milestone payment provides us with significant additional non-dilutive capital to continue our development of our first-in-class, network-targeted EGFR, Her2 and HDAC inhibitor CUDC-101 and other preclinical network-targeted agents, including an HDAC and Pi3K inhibitor, which we expect to advance as a development candidate in 2010," said Mike Gray, Curis’ Chief Financial Officer. "Curis currently has adequate cash to fund its operations well into the first half of 2012, not including any additional potential future milestone payments from our collaborations with Genentech and Debiopharm."
Shares of Curis closed up 20 cents or 8.66% to close at $2.51.
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) shares traded down today as the company announced that it has priced an underwritten public offering of 11,764,706 newly issued units at a public offering price of US$1.70 per unit. Each unit is comprised of one of the Company's common shares and a warrant to purchase 0.5 of a common share. Each whole warrant entitles the holder to acquire one common share of the Company upon payment of US$2.30 per share, exercisable at any time during the period beginning six months after the date of issuance and ending three years following the date of issuance. The gross proceeds to Labopharm, before underwriting discounts and commissions and other offering expenses, from the sale of the units are expected to be approximately US$20 million. Labopharm closed down 41 cents to close the day at $1.71.
In other news from a relatively quiet, pre-holiday Friday:
Agilent Technologies Inc. (NYSE: A) today reported revenues of $1.21 billion for the first fiscal quarter ended Jan. 31, 2010, 4 percent above one year ago.
Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it will host a conference call and Webcast on Thursday, February 25, 2010, at 8:30 a.m. EST, for Company executives to discuss fourth-quarter 2009 financial and operational results.
Catalyst Health Solutions, Inc. (NASDAQ: CHSI), a pharmacy benefit management company, will release its fourth quarter earnings results on Tuesday, February 23, 2010, after the market closes.
CryoPort, Inc. (OTCBB: CYRXD) (NASDAQ:CYPT) today announced that it has decided to postpone its contemplated public offering of units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock, due to unfavorable market conditions.
Endo Pharmaceuticals (Nasdaq: ENDP) will announce its fourth quarter and full year 2009 financial results on February 22, 2010 and will host a conference call and webcast at 10:30 a.m. ET that day to discuss these results.
Helix BioPharma Corp. (TSX, FSE: HBP; Pink Sheets: HXBPF) today announced that the first ten patients that have been enrolled in its Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.
Idant Laboratories, a subsidiary of the medical instrumentation and biotechnology company Daxor Corporation (NYSE Amex: DXR), today announced that it received a blood banking contract from Rotenberg, Meril, Solomon, Bertiger & Guttilla (RMSB&G).
IntegraMed America, Inc. (NASDAQ: INMD) today announced that it has priced a public offering of 2,500,000 shares of its common stock at a price to the public of $7.50 per share, of which 2,000,000 shares are being offered through the underwriters named below and 500,000 shares are being offered directly by IntegraMed to IAT Reinsurance Company Ltd., IntegraMed’s largest stockholder.
The approximately $17 million of net proceeds, after deducting underwriting discounts, commissions and expected offering expenses payable by IntegraMed, are intended to be used to accelerate the addition of new partner fertility centers, to accelerate the pace of new vein clinic openings in 2010, or for general working capital and other corporate purposes. The offering is expected to close on or about February 18, 2010, subject to the satisfaction of customary closing conditions.
The underwriters have been granted a 30-day option to purchase up to an additional 300,000 shares to cover over-allotments, if any
International Merchant Advisors, Inc. (Pink Sheets: IMAI) announced today that the company has formally offered to purchase an equity position in a pharmaceutical operation that is focused on selling in the chronic pain management medical sector.
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a specialty pharmaceutical company focused on difficult-to-formulate drugs, today announced the appointment of Graham Neil, CA, as Chief Financial Officer and Vice-President, Finance.
Mr. Neil is a Chartered Accountant with over 10 years of public company and healthcare industry experience. Most recently Mr. Neil served as CFO for a NASDAQ- and TSX-listed development-stage company. Prior to his public company experience, Mr. Neil served with KPMG.
"We are very pleased to announce the appointment of Graham Neil to the position of CFO and VP of Finance," commented Dr. Isa Odidi, Chief Executive Officer and co-founder of Intellipharmaceutics. "Graham will be a very valuable addition to our executive team as we advance our pipeline of products, including our lead product candidate Dexmethylphenidate XR, a generic version of the marketed drug Focalin XR®. This product is partnered with Par Pharmaceutical and is currently the subject of an Abbreviated New Drug Application filing with the FDA."
MMR Information Systems, Inc. (OTCBB:MMRF) Dear Shareholder: As we go into the long Valentine's and Presidents Day holiday weekend, I want to take this opportunity to express MMR Information Systems' appreciation for your support as we mark our first anniversary as a public company.Time goes fast when you are committed to a vision.
NeoStem, Inc. (NYSE Amex: NBS), an international biopharmaceutical company with operations in the U.S. and China, announced today that it priced a public offering of 5,000,000 shares of its common stock at $1.35 per share. Net proceeds from the offering, after underwriting discounts and commissions and expenses, will be approximately $5,697,500. NeoStem has granted the underwriters an option to purchase up to an additional 750,000 shares to cover over-allotments, if any.
"We were pleased by the participation of new institutional investors as well as the additional investment by our largest shareholder and other insider participation," noted Dr. Robin Smith, Chairman and CEO. "We remain committed to expanding our revenue opportunities in China, both through our pharmaceutical business and soon to be launched adult stem cell initiatives. The proceeds of this offering will help us reach our goals."
The Company intends to use the net proceeds from this offering for the construction of manufacturing and lab facilities in China and the U.S., stem cell-related research and development projects, development and licensing of new pharmaceutical products in China, and for working capital and general corporate purposes.
Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, today announced that it has hired MTS Health Partners, L.P. as strategic advisor to complement and augment the company’s ongoing business development activities.
Perrigo Company (Nasdaq: PRGO) announced today that a federal court has granted summary judgment in its favor in patent litigation involving Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex® tablets. Perrigo had been sued by Adams Respiratory Therapeutics, Inc., (a subsidiary of Reckitt Benckiser Group plc.) the New Drug Application holder and patent owner. The United States District Court for the Western District of Michigan ruled today that Perrigo does not infringe the patent in the suit. Perrigo's ANDA is awaiting FDA approval.
Perrigo's Chairman and CEO Joseph C. Papa stated,This is another example of Perrigo's significant investment and commitment to bringing new store brand products to the market. This will be an important new store brand product addition in the cough/cold category to our retail and wholesale customers while providing significant savings for the U.S. consumer. Perrigo is working every day to make quality healthcare more affordable.
Rexahn Pharmaceuticals (AMEX:RNN) continued its rally, closing up over 28% on heavy volume to close the day at $1.22. The shares are up over 50 cents or 80% since BioMedReports first reported on the company on Tuesday.
Senomyx, Inc. (NASDAQ: SNMX) announced today the pricing of an underwritten public offering of 7,142,857 shares of its common stock at a price to the public of $2.80 per share.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) was up over 17.5% on more than double the normal volume to close at $1.07 on no apparent news.
3SBio Inc. (Nasdaq:SSRX), a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, announced late last night (Thursday) that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA). NuPIAO is a highly glycosylated ESA (erythropoiesis-stimulating agent) with extended half-life and increased biologic activity. Pre-clinical results showed a promising pharmacokinetic profile which would allow a once weekly injection schedule of NuPIAO in humans. NuPIAO will be investigated to treat anemia associated with both chronic kidney disease and cancer.
"This submission represents another important milestone in our effort to extend our market leading EPO franchise and continue to serve the needs of patients in China," said Dr. Jing Lou, CEO of 3SBio. "It is a direct result of our dedicated R&D effort to generate an innovative pipeline and create long term value for shareholders."
In a separate release 3SBio announced that they have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis with Ascentage Pharma Group Corporation, Ltd.. The alliance will leverage Ascentage Pharma's expertise in structure-based small molecule design, lead optimization and pre clinical development with 3SBio's proven drug development and commercialization capabilities in China.
Under the terms of the agreement, 3SBio will make a US$3 million equity investment in Ascentage Pharma. The investment will be used to fund Ascentage Pharma's R&D programs. 3SBio will have the exclusive right to develop and commercialize cancer therapeutics in China that are discovered through Ascentage Pharma programs, while Ascentage Pharma will retain the rights to the rest of the world and receive future milestone and royalty payments from any sales by 3SBio in China.
"The collaboration with Ascentage Pharma represents a key strategic initiative for 3SBio to develop our pipeline in the area of cancer therapeutics," said Dr. Jing Lou, CEO of 3SBio. "This investment allows 3SBio to gain access to the best external science and small molecule drug discovery platform in China."
And finally, the company also announced its unaudited financial results for the fourth quarter and full year ended December 31, 2009.
Shares traded higher on Friday by 16 cents to close at $11.15.
Walgreens (NYSE: WAG)(NASDAQ: WAG) will continue filling Medicaid prescriptions at its Washington state pharmacies through March 15.