Monday, October 1, 2018
Sangamo, TxCell announce completion of acquisition of TxCell ordinary shares
Sangamo Therapeutics and TxCell jointly announced the completion by Sangamo of the acquisition of ordinary shares of TxCell, at a price of EURO$2.58 per share in cash, representing approximately 53% of the share capital and voting rights of TxCell, as per the terms of the Share Purchase Agreement entered into on July 20, 2018 and announced previously by TxCell and Sangamo in a joint press release dated July 23, 2018. TxCell will now operate as a subsidiary of Sangamo. Sangamo expects to file on October 2, 2018 a cash simplified tender offer for the purchase of all then outstanding ordinary shares of TxCell, at a price of EURO$2.58 per share. Subject to obtaining at least 95% of the share capital and voting rights of TxCell upon completion of the simplified tender offer, Sangamo will launch a squeeze-out procedure. Following the completion of the squeeze-out procedure, Sangamo will delist TxCell. TxCell’s operations will remain based in Valbonne, France.
https://thefly.com/landingPageNews.php?id=2797685
Akorn hit after Judge rules Fresenius can pull out of takeover
Shares of Akorn (AKRX) are sinking after Delaware Chancery Court Judge Travis Laster ruled that Fresenius (FSNUY) has proper grounds for canceling its $34 per share buyout of the generic drugmaker. The judge, in a 246-page opinion, said that Fresenius “properly exercised its rights” to withdraw from the deal, according to Bloomberg. Before being halted for news, shares of Akorn dropped 47%, or $6.08, to $6.90.
Mallinckrodt Responds to CBS’ 60 Minutes Segment
Mallinckrodt responded to questions received from CBS’ 60 Minutes and provided the following statement:
Mallinckrodt never sold or sent oxycodone or any products to Dr. Schultz, and based on a thorough review of our records, we had no communication with him. As a manufacturer, we do not ship products to independent retail pharmacies, prescribing physicians or end users. We sell only to distributors, and have always complied with our obligation to report suspicious orders from those customers. Mallinckrodt has limited information about shipment of our products between distributors and pharmacies, but with the information available to us, we work closely with law enforcement to combat diversion.
Dr Reddy’s to launch generic Gleevec in US
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Imatinib Mesylate Tablets, USP, a therapeutic equivalent generic version of Gleevec (imatinib mesylate) Tablets in the United States market approved by the U.S. Food and Drug Administration (USFDA).
The Gleevec brand and generic had U.S. sales of approximately $868 million MAT for the most recent twelve months ending in July 2018 according to IMS Health*.
Dr. Reddy’s Imatinib Mesylate Tablets, USP is available in 100 mg 30 count bottle size and 400 mg 90 count bottle size.
Gleevec is a trademark of Novartis Pharmaceuticals Corporation.
Novartis, Adamis keep swinging at EpiPen with Symjepi pediatric dose
Novartis’ Sandoz is getting ready to stir things up in the adult epinephrine market—and as of Thursday, it has a green light to stir things up in the pediatric epinephrine market, too.
The generics giant’s partner, Adamis, has snagged an FDA approval for a .15 mg dose of Symjepi, a prefilled syringe used for emergency treatment of severe allergic reactions. The smaller dose, which is half the volume of the .3 mg dose the agency OK’d last June, is meant for children who weigh between 33 and 65 pounds.
Sandoz, which is gravitating toward more complex products as pricing pressure hurts easy-to-make generic pills, will market the pediatric offering in the U.S., thanks to a July deal it struck with San Diego-based Adamis. The pact between the two also handed Sandoz distribution and commercialization rights for the larger dose.
For decades, Mylan’s Epi-Pen has dominated the epinephrine market, but in recent years, pricing scandals have opened the doors for low-cost competition. Adamis, which snagged the FDA’s favor after an initial rejection, last year pledged to position the not-yet-launched .3 mg version “as a low-cost alternative to the other current offerings in the anaphylaxis market,” an Adamis spokesman told FiercePharma via email.
The pediatric offering will also represent “an affordable alternative to current treatment offerings at a time when patients need access to this medicine most,” Sandoz President Carol Lynch said in a statement, adding that, “We are committed to reimagining their care by bringing this valuable, life-saving medicine in a prefilled epinephrine syringe to the U.S. market as soon as possible.”
That’s not to say grabbing market share will be an easy task. Lower-dose Symjepi will go up against not only a .15 mg dose of EpiPen, but a .15 mg dose of its generic, which Teva cleared with the FDA last month. Rival Auvi-Q from Kaléo also boasts a .15 mg dose, as well as the market’s only .1 mg dose for infants and toddlers. And it’ll be looking to keep patients who start on Auvi-Q as young children on the brand as they advance to the .15 mg dose.
Innovent doses 1st patient in Phase 3 lung cancer antibody trial
Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-12) studying sintilimab, a fully human anti-PD-1 monoclonal antibody (IBI-308), as first-line treatment for patients with previously untreated squamous non-small cell lung cancer (NSCLC).
The ORIENT-12 study is a randomized, double-blinded trial conducted in China to evaluate the efficacy and safety of sintilimab or placebo combined with gemcitabine and platinum-based chemotherapy for first-line treatment of advanced or recurrent squamous NSCLC. The phase III study will enroll 348 patients. The study follows on the phase Ib study cohort E that evaluated sintilimab in combination with gemcitabine and cisplatin for first-line treatment of advanced squamous NSCLC. The detailed results of the study will be published in the recent academic conference.
“Advanced squamous non-small cell lung cancer is not suitable for the application of targeted drugs due to the lack of driver genes, and is not suitable for anti-angiogenic drugs. Immunological checkpoint inhibitors bring new hope to patients with squamous NSCLC. Based on the good efficacy and safety of the previous trials, we hope to validate the therapeutic value of the regimen of sintilimab in combination with chemotherapy in the phase III trial of ORIENT-12,” said Professor Caicun Zhou, from the Shanghai Pulmonary Hospital.
“Lung cancer is the most common malignant tumor in China with the highest morbidity and mortality. The development of advanced squamous NSCLC related therapeutic drugs has been stagnant, and there is a huge unmet clinical need. Based on the encouraging efficacy we observed in our phase Ib study of the first-line treatment of advanced squamous NSCLC with sintilimab combined to chemotherapy, we decided to conduct the ORIENT-12 study. The study was the first phase III study in the world to evaluate anti-PD-1 mAb combined with gemcitabine and platinum regimens in the treatment of advanced squamous NSCLC. I hope that the clinical research of sintilimab in this field will be carried out smoothly, so that more cancer patients and families can benefit from the therapy as soon as possible,” said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.
Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate to provide support to the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic partnerships of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.
FDA Action Alert: Ortho Dermatologics, Akcea Therapeutics and Merck
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
The FDA originally had a target action date of October 5 for Acorda Therapeutics’ New Drug Application for Inbrija (levodopa inhalation powder) to treat symptoms of OFF periods of Parkinson’s disease patients taking a carbidopa/levodopa regimen. However, on September 13, the company announced that the agency had extended the PDUFA date to January 5, 2019, related to recent submissions the company made after the FDA asked for more data on chemistry, manufacturing and controls (CMC). The FDA decided the submissions were a major amendment that required more time to review.
Ortho Dermatologics, a division of Valeant Pharmaceuticals (now named Bausch Health) has a PDUFA date of October 5 for its NDA for Jemdel (halobetasol propionate) lotion for plaque psoriasis with dosing for as long as eight weeks. In February, Bausch Health chairman and chief executive officer, Joseph C. Papa, stated, “The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition. If approved, we believe Jemdel will be an important option for patients with plaque psoriasis.”
Verastem had an October 5 target action date for its NDA for full approval of duvelisib for patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). However, on September 24, the FDA approved Copiktra for those indications.
“With Today’s FDA approval of Copiktra, Verastem oncology is delivering upon our commitment to patients with cancer by bringing a new oral medicine to market,” stated Robert Forrester,president and chief executive officer of Verastem Oncology. “We are pleased to be able to introduce Copiktra during National Blood Cancer Awareness Month. At Verastem Oncology, we are driven by the strength and courage of those battling cancer, and we are committed to advancing therapies such as Copiktra with the potential to make a significant impact for patients, their caregivers and physicians.”
Akcea Therapeutics has a PDUFA target date of October 6 for Tegsedi (inotersen) for stage 1 or stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis (hATTR). The drug was approved for those indications in Europe in July. The drug was approved by the European Commission (EC) based on results from the Phase III NEURO-TTR trial.
“With the EC’s decision, Tegsedi is now the world’s first and only RNA-targeted therapeutic approved for patients with hATTR amyloidosis,” stated Paula Soteropoulos, Akcea’s chief executive officer. “With subcutaneous delivery, Tegsedi puts treatment in the patients’ hands while bringing the significant benefits shown in the NEURO-TTR study in both measures of neuropathy and quality of life for people living with this serious and fatal disease.”
Merck has a PDUFA date of October 6 for a supplemental Biologics License Application (sBLA) for Gardasil, the company’s 9-valent Human Papillomavirus (HPV) vaccine. The request is to expand the age indication for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases associated with the nine HPV types covered by the vaccine.
Alain Luxembourg, director of Merck’s clinical research, told HemOnc Today, “Exposure to HPV does not stop at age 26 years. We now have a significant amount of epidemiological and real-world data that show adults older than age 26 years are exposed to HPV and are susceptible to infection. We have a population that is at risk and is not protected.”
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