The Business Cocktail

PMV Pharma Raises $74M, Aiming to Hit Cancer’s Hard Target- P53

PMV Pharmaceuticals is the latest startup to load up with cash in an attempt to home in on one of the toughest targets in cancer biology: the tumor suppressor protein known as p53. The company raised a $74 million Series B round from Topspin Biotech Fund, Euclidian Capital, InterWest Partners, OrbiMed Advisors, and Osage University Partners. PMV raised a $30 million Series A in 2014. The new cash will help PMV push into human clinical studies, though in its statement the startup didn’t say when those studies might begin. Like many of its peers, PMV wants to restore the function of mutated p53 with a drug, though it didn’t disclose exactly what its approach will be.

Argos Shares Plummet following Reports of Failed Results for Kidney Cancer Therapy

An Argos Therapeutics therapy that uses the immune system to fight kidney cancer has hit a wall after an analysis of the latest clinical trial data found that the experimental treatment was unlikely to work. Following the planned interim analysis of Argos’s Phase 3 clinical trial, the independent data monitoring committee recommended stopping the study for futility, the company announced this morning. Shares in Durham, NC-based Argos plummeted more than 62 percent to $1.65 on the news. Argos said that it is analyzing the preliminary data from the clinical trial and it plans to discuss that information with the FDA. In the meantime, Argos said that it plans to leave the clinical trial open.

Cidara Antifungal Flunks in Phase 2 Clinical Trial, Shares Sink

Cidara Therapeutics is halting work on an experimental topical antifungal drug designed to treat vaginal yeast infections after the compound wasn’t better than the current standard of care in a Phase 2 clinical trial. Investors frowned on the news, sending the company’s shares down more than 38 percent to $7.24 on 21st morning. Cidara is turning its attention to CD101 IV, which is in a Phase 2 trial for the fungal infection candidemia. Results for that clinical trial are expected in the fourth quarter. Cidara will also continue working on CD201, a potential treatment for infections caused by drug-resistant Gram-negative bacteria.

Cashing in On Duchenne Approval, Sarepta Sells Voucher to Gilead for $125M

Sarepta Therapeutics didn’t just get its first drug to market when the FDA approved the Duchenne muscular dystrophy drug eteplirsen (Exondys 51) last year—it got a potentially lucrative voucher from the FDA too. Sarepta sold the priority review voucher to Gilead Sciences in a deal worth $125 million. Sarepta will use the cash to help develop next-gen drugs for Duchenne. Priority review vouchers are awarded to companies that bring treatments to market for neglected tropical diseases and rare pediatric ailments, enabling a swifter review from the FDA, and potentially adding millions in revenue for a company, or giving a drugmaker a leg up over a competitor with a rival therapy.

Novartis and NHS Ayrshire & Arran launch new eye care facility in Scotland

Novartis Pharmaceuticals UK and NHS Ayrshire & Arran have announced the launch of a new facility designed specifically for people suffering from some of the most common forms of avoidable sight loss. The facility is set to support the delivery of a one-stop clinic for patients and is expected to transform the patients’ eye service by building an extension on to the existing Ophthalmology Outpatient Department.

The Business Cocktail

ALCMI, ALCF and Scancell partner to evaluate SCIB2 cancer vaccine for NSCLC

The Addario Lung Cancer Medical Institute (ALCMI) and the Bonnie J. Addario Lung Cancer Foundation (ALCF) have collaborated with UK-based Scancell to assess SCIB2 cancer vaccine to treat patients with non-small-cell lung cancer (NSCLC). SCIB2 is Scancell’s second ImmunoBody cancer vaccine platform currently under development. It stimulates the immune system to potentially treat and prevent cancer. Scancell has successfully completed a Phase I / II clinical trial with SCIB1 cancer vaccine by using it on patients suffering from melanoma. Along with having the ability to complement existing treatments, SCIB2 can also work in cases where current treatments either do not work or are not available.

Sun looks to unload Ohm Labs New Jersey plants in manufacturing consolidation

The Indian company is reportedly looking to sell New Jersey plants as part of a manufacturing consolidation. The facilities have been on the market for a couple of months and are expected to fetch about $100 million. Sun Pharma got the solid-dose, prescription and OTC manufacturing facilities in its 2015 buyout of Ranbaxy Laboratories, and is slimming down its manufacturing operations since the buyout, last year selling plants in Philadelphia, Pennsylvania, and Aurora, Illinois, to CDMO Frontida BioPharm. Before that, it struck a deal to sell a formulation plant in Bryan, Ohio, to Nostrum Laboratories, a Kansas City, MO-based generics maker, and announced the closure of a plant in Tipperary, Ireland.

Takeda and Ovid join forces to co-develop Drug for Rare Pediatric Epilepsies

In January 2017, Takeda and Ovid Therapeutics announced an agreement to co-develop a drug for rare pediatric epilepsies. Takeda’s compound, TAK-935, is at the heart of this agreement, with its continued development and commercialization in the US, Europe, Canada, and Israel being conducted by Ovid. Takeda will be developing the drug in Japan and other Asian markets. This unusual agreement also allows the companies to share the development and commercialization costs 50/50, and in the event of a successful launch to share profits equally as well.

Guardant and MD Anderson collaborate for liquid biopsy deal

Guardant Health and the University of Texas MD Anderson Cancer Center have struck a multiyear deal to push comprehensive liquid biopsy into the standard of care in cancer treatment. The commercial, research and development agreement will see Guardant helping MD Anderson build multiple liquid biopsy centers on site, according to a statement. The company launched its Guardant360 test in 2014 and says it is the most validated and sensitive liquid biopsy on the market.

Glooko and Ascensia integrate their offerings to boost diabetes management

In its second partnership announced this month, Glooko is teaming with Ascensia Diabetes Care to connect the latter’s blood glucose monitoring systems to its diabetes data management platform. Under the partnership, the pair will integrate Ascensia’s Contour Next One and Contour Plus One systems into Glooko’s platform. The goal is to improve diabetes data management and analytics for patients and physicians. Earlier this month, Glooko and Novo Nordisk joined forces to develop “digital health solutions” for diabetes management.

 

The Business Cocktail

Sun Pharma & ICGEB announce exclusive collaboration to develop novel dengue vaccine

International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma Ltd. announced their new collaboration for development of a dengue vaccine, targeted against all the four serotypes of Dengue virus that cause disease in humans. ICGEB has developed a tailored recombinant virus-like-particle (VLP) based tetravalent dengue vaccine, containing host-receptor binding domain of envelope protein of all the four DENV serotypes. ICGEB has conducted pre-clinical studies over the past seven years and developed the existing Know-How and Patents for this dengue vaccine candidate.

Boehringer Ingelheim and Lupin Sign agreement for Diabetes Drug

Drug firms Boehringer Ingelheim and Lupin have entered into a partnership to co-market Empagliflozin used for treatment of type 2 diabetes in India. Lupin will market and sell Empagliflozin under a separate brand name Gibtulio which will be promoted by Lupin’s specialty field force. Boehringer Ingelheim will continue to sell Empagliflozin under the brand name Jardiance through their existing sales force and network

Daiichi Sankyo Announces New Strategic Immuno-Oncology Research Collaboration with AgonOx

Daiichi Sankyo announced that it has entered into a strategic collaboration with AgonOx, Inc., a privately held biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, to develop an undisclosed immuno-oncology target. Daiichi Sankyo and AgonOx will collaborate on preclinical development of the program. Following preclinical assessment, Daiichi Sankyo has an exclusive option to research, develop, manufacture and commercialize the program worldwide

Catalent Pharma Solutions partners with Samsung Bioepis Co. for Commercial Biosimilar supply

Catalent Pharma Solutions announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel® (etanercept), on behalf of the Korea-based biopharmaceutical company Samsung Bioepis Co., Ltd. The services will be provided at Catalent’s flagship sterile pre-filled syringe facility in Brussels, Belgium. SB4 is the first etanercept biosimilar to receive regulatory approval by the European Commission (EC), as Benepali.

Celltrion Healthcare and Teva enters into exclusive business collaboration agreement for Truxima™ and Herzuma™ in the U.S. and Canada

Celltrion’s commercial partner for its second and third biosimilars for the North America market has been determined. Celltrion announced that it has selected Teva Pharmaceuticals, as its exclusive commercial partner for Truxima and Herzuma in the US and Canada. Celltrion has applied for marketing authorization from the EMA last October. Mabthera (also known as Rituxan), the reference product to Truxima, was developed by Biogen and marketed by Roche.  Herzuma is a biosimilar to Herceptin, a breast cancer treatment antibody biologic drug developed by Genentech and marketed by Roche.