Knight Sells Priority Review Voucher to Gilead

MONTREAL, QUEBEC--( Nov 19, 2014) - Knight Therapeutics Inc., (GUD.TO) through one of its wholly owned subsidiaries ("Knight"), today announced the sale of its Neglected Tropical Disease Priority Review Voucher ("PRV"). The PRV was granted to Knight in March of this year with the approval of Impavido® (miltefosine) for treatment of patients with visceral, mucosal and cutaneous leishmaniasis. Upon closing of the transaction, Knight will receive US$125 million in cash from Gilead Sciences, Inc. in exchange for the PRV. Knight was advised in the transaction by global investment banking firm, Jefferies LLC.

"We are thrilled to successfully transfer our priority review voucher in expectation that this will encourage others to invest in R&D for neglected tropical diseases for the benefit of humanity" said Jonathan Ross Goodman, Director of Knight.

Published: 19 November 2014
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Orexigen Therapeutics Reports Results for the Third Quarter Ended September 30, 2014

SAN DIEGO, Nov. 10, 2014 -- Orexigen® Therapeutics, Inc. (OREX), a biopharmaceutical company focused on the treatment of obesity, today announced results for the third quarter ended September 30, 2014.

"We are thrilled that Contrave® (naltrexone HCl / bupropion HCl extended release) is now available to patients," said Michael Narachi, CEO of Orexigen. "In addition to strong commercial resourcing, Takeda is bringing innovative approaches to the Contrave launch, by supporting the patient's complete approach to weight management with companion programs such as a weight loss program called Scale Down as well as Contrave Direct Save."

Published: 10 November 2014
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Dynavax Announces Independent DSMB Recommendation to Continue Phase 3 Study of HEPLISAV-B(TM)

BERKELEY, CA--(Marketwired - Nov 10, 2014) - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine, has completed its first prespecified review and has recommended that the study continue unchanged.

 

This large safety and immunogenicity study (known as HBV-23) is observer-blinded, randomized, and active-controlled. Adult subjects were randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B®. The DSMB for HBV-23 is an independent panel of physicians otherwise unaffiliated with the study that is charged with performing at least three comprehensive reviews of interim safety data at predetermined time points.

Published: 10 November 2014
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Alexza and Ferrer Expand ADASUVE® Partnership

Ferrer Purchases $8 Million of Alexza Common Stock through New Investment and Elimination of Potential Milestone Payments

MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Oct. 27, 2014 -- Alexza Pharmaceuticals, Inc. (ALXA) and Grupo Ferrer Internacional, S.A. (Ferrer) announced today that they have amended their agreement for ADASUVE® (Staccato® loxapine).  Ferrer is Alexza's commercial partner for ADASUVE in the European Union, Latin America and the Commonwealth of Independent States countries (the Ferrer Territory). Ferrer and Alexza have agreed that Ferrer will purchase 2 million shares of Alexza common stock for $4.00 per share, thereby becoming the Company's largest shareholder. The purchase represents a combination of new investment and consideration for the elimination of certain future potential milestone payments under the agreement.

Published: 27 October 2014
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Takeda and Orexigen Announce Availability of CONTRAVE® (naltrexone HCI and bupropion HCI) Extended-Release Tablets for Chronic Weight Management in Obese Adults

Contrave is now available by prescription, and Contrave patients also have access to the Scale Down program and Direct Save to help support their complete approach to weight management

DEERFIELD, Ill. and OSAKA, Japan, Oct. 20, 2014 -- Takeda Pharmaceutical Company Limited ("Takeda"), its wholly-owned subsidiary Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (OREX) jointly announced today that Contrave® (naltrexone HCI and bupropion HCI) extended-release tablets are now available to patients by prescription in pharmacies across the United States. Contrave is approved by the U.S. Food and Drug Administration (FDA) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).

Published: 21 October 2014
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