Today - Friday, March 6, 2015
- The German Court of Appeal rules that Eli Lilly's (NYSE:LLY) vitamin regimen patent for its cancer drug Alimta (pemetrexed disodium) would not be infringed by a generic competitor that intends to market a dipotassium salt form of pemetrexed in Germany once the compound patent expires in December. The decision vacated the prior decision of the Regional Court of Dusseldorf in April of last year.
- Lilly SVP and General Counsel Michael J. Harrington says, "We strongly disagree with the ruling by the German Court of Appeal regarding Alimta's vitamin regimen patent. Although, Alimta's compound patent remains in force and is expected to provide exclusivity in Germany through December 2015, we continue to believe that Alimta's vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June 2021. We will seek permission to appeal this ruling to the German Supreme Court."
- In April 2014, the English High Court made a similar ruling pertaining to alternative salt forms of pemetrexed in the U.K., Italy, France and Spain. The appeal of the decision in pending and is scheduled for hearing starting March 9.
- Lilly's vitamin regimen patent was upheld in a prior ruling by the Opposition Division of the European Patent Office. An appeal is pending before the Technical Board of Appeal of the European Patent Office.
- Thinly-traded micro cap Calithera Biosciences (NASDAQ:CALA) is up 37% premarket on modest volume in response to its deal with High Point Pharmaceuticals and TransTech Pharma to develop and commercialize High Point's hexokinase 2 inhibitors for the treatment of cancer.
- Previously: Calithera Bio inks development deal for cancer drug candidates (March 5)
- In a trial over injuries blamed on the TVT Abbrevo transvaginal mesh, a California jury ordered Johnson & Johnson's (NYSE:JNJ) Ethicon unit to pay $5.7M to plaintiff Coleen Perry. After more than three days of deliberation in Kern County, jurors found Ethicon liable for problems with the design of TVT Abbrevo and failing to warn patients about its risks. Ms. Perry was awarded $700K in compensatory damages and $5M in punitive damages.
- The verdict is the fourth win for plaintiffs suing the company over the product. More than 36,000 lawsuits have been filed in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The FDA cleared it for sale in 2010.
- Ethicon won one trial in federal court in West Virginia, where another one started on Monday. Ethicon spokesman Matthew Johnson says the company believes it has strong grounds for an appeal of the California verdict. He says Ethicon stands behind the safety and effectiveness of Abbrevo, as well as its development and marketing.
- Ethicon, Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR) face more than 70,000 mesh injury lawsuits in federal court and thousands more in state courts. In December, a federal judge advised Bard to settle more than 12,000 lawsuits in light of the large verdicts awarded to date.
- Previously: Judge advises Bard to settle mesh lawsuits (Dec. 12, 2014)
- Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
- Sunshine Heart (NASDAQ:SSH) suspends patient enrollment in the Phase 3 clinical trial evaluating its C-Pulse Heart Assist System in patients with NYHA Class III and ambulatory Class IV heart failure after four of the first twenty patients died. Two have been adjudicated by an independent Clinical Events Committee as being non-device related. The company has received documentation from the sites that reported the most recent two deaths that these were also non-device related. Currently enrolled patients will continue follow-up according to the study protocol.
- The FDA has advised Sunshine to file an IDE supplement that addresses the reasons for the temporary suspension of the trial and a plan for its resumption. The company intends to submit the document by March 16.
- CEO Dave Rosa says, "We are confident this matter will be resolved in a very short time frame. While the current data suggest these incidents are non-device related, we have decided that in the absolute interest of patient safety, having a temporary pause in enrollment is the right course of action while we work with the FDA to discuss the findings."
- One of the study's principal investigators, Dr. Bill Abraham, will be available during the company's March 17 earnings call to answer questions.
- SSH is down 30% premarket on robust volume.
- Amarin (NASDAQ:AMRN) enters into a definitive securities subscription agreement with institutional investors, both existing and new, for the private placement of up to a maximum of $52.8M of restricted American Depositary Shares at $0.15, each representing one share of the company's non-voting Series A Convertible Preference Shares.
- Each ten Series A Convertible Preference Shares may be consolidated and redesignated as one ordinary share up to a maximum aggregate of 35,215,079 ordinary shares.
- Net proceeds of ~$52.2M will fund the commercialization of Vascepa, advance the REDUCE-IT cardiovascular outcomes trial and general corporate purposes.
Thursday, March 5, 2015
- Thinly-traded nano cap Targacept (NASDAQ:TRGT) and privately-held South San Francisco-based Catalyst Biosciences agree to merge. The new entity will be named Catalyst Biosciences and will have the anticipated stock symbol "CBIO." Catalyst CEO Nassim Usman, Ph.D., will be President and CEO of the combined firm.
- Catalyst shareholders will initially own ~65% of the combined company. Targacept shareholders will own ~35% and will receive a dividend of an aggregate of $37M in non-interest bearing redeemable convertible notes and ~$20M in cash. The notes will be convertible into the new entity's common stock at any time within two years after the deal closes, at the noteholders' discretion, for $1.31 per share which is 130% of the negotiated per-share value of Targacept's assets after the distribution of the dividend.
- Catalyst's product development activities focus on hemostasis and complement regulation. Its lead product is CB 813d for hemophilia. Targacept focuses on a class of products called neuronal nicotinic receptors. Its lead product is TC499 for the treatment of diabetic gastroparesis. Both are in Phase 1 development.
- TRGT is down 3% after hours on high volume.
- Calithera Biosciences (NASDAQ:CALA) enters into a license and research agreement with High Point Pharmaceuticals, LLC and TransTech Pharma LLC to develop and commercialize High Point's hexokinase 2 inhibitors for the treatment of cancer.
- Under the terms of the agreement, Calithera will pay High Point an initial license fee of $600K, up to $30.5M in regulatory milestones for the first licensed product, up to $77.0M in sales-based milestones and mid-single-digit royalties on net sales. The license agreement will continue on a product-by-product and country-by-country basis.
- Cancer cells preferentially use a high rate of aerobic glycolysis to support their growth which is commonly called the "Warburg effect." Malignant rapidly growing tumor cells can have glycolytic rates up to 200x higher than normal cells. Hexokinases play a key role in glycolysis so inhibiting their activity inhibits glycolysis and slows the growth of cancer cells.
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