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

Payers block Kaléo’s expensive EpiPen challenger

Kaléo reintroduced its Auvi-Q last week at a list price of $4,500 for a two-pack in an effort to capture some market share from Mylan’s EpiPen, which is listed at about $600 for a two-pack. Auvi-Q is set to launch next month. Under Kaléo’s pricing strategy, Auvi-Q will cost most patients $0 out-of-pocket. If an insurer refuses to cover the med, the company will step in and pay for that access, execs said last week. Uninsured patients can purchase the drug at a cash price of $360 for a two-pack. Instead, the strategy shifts the costs to insurers and pharmacy benefit managers. At a list price multiples higher than its competition, Kaléo Pharma’s revived Auvi-Q has hit resistance from some of the nation’s top pharmacy benefit managers and insurers. Cigna has said no to the idea, while Humana is not talking to the company and Aetna is restricting its product for now.

FTC settlement clears Endo from pay-for-delay liability; Watson, Allergan charged

According to the FTC complaint, Lidoderm was an important product for Endo back in 2011. That year, the company made $825 million in sales off the lidocaine patch, or 30% of its annual sales haul, meaning generic competition would pose “significant financial risks” to the company. Endo paid Watson at least $250 million to delay that competition, according to the feds. Through an “administrative complaint,” authorities are also going after Impax Laboratories, which they say received $112 million back in 2010 to delay a generic competitor to Endo’s Opana ER. Endo International has pledged to swear off pay-for-delay agreements. But even as the government moves to wrap up its case against Endo, authorities continue to pursue claims against Watson and Allergan.

Amgen hikes prices by single digits, with Enbrel matching AbbVie’s Humira boost

Amgen raised the price of its top-selling med, Enbrel, an 8.4% hike that followed a larger one just six months ago. It also came on the heels of an identical price hike for one of Enbrel’s key competitors, AbbVie’s Humira. Amgen executives say payer discounts will eat up most if not all of its latest hikes. The move follows a 28% increase for the anti-TNF blockbuster in 2015 and another boost of 9.9% in July 2016. During Amgen’s third-quarter 2016 conference call, commercial operations head Anthony Hooper said the company expects “relatively little benefit” on Amgen price changes in 2017 due to competitive payer negotiations.

Baxter paying $18M to settle federal case over sterile plant failings

Ignoring issues in a sterile manufacturing plant can lead to big problems, like FDA warning letters, which Baxter International received for a plant in North Carolina after mold was found in HEPA filters. But in rare cases, it can lead to even more severe penalties, like the $18 million-plus Baxter will pay to resolve a federal criminal case, as well as a civil matter brought by a whistleblower over the mold concerns.  Baxter will pay another $2.158 million to resolve a civil whistleblower case brought by Baxter employee Christopher Wall who had reported to the mold problem to plant management. Wall’s case alleged his concerns were overlooked and the plant continued to manufacture and sell product from the facility. Wall gets $431,535.99 as his share of the settlement.