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.

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Mead Johnson Acquired By Reckitt Benckiser for $16.6 Billion

Mead Johnson Nutrition Company (MJN), the manufacturer of infant formula and nutritional supplements, has agreed to be acquired by Britain’s Reckitt Benckiser Group plc in a deal that values the former’s equity at $16.6 billion. Mead Johnson shareholders will receive $90 in cash for each share. Adding the company’s net debt brings the total value of the transaction to $17.9 billion and the deal is expected to close by the end of Q3 2017. RB expects the integration to deliver cost savings of 200 million pounds per annum by the end of the third full year, and it says the acquisition will be accretive to adjusted diluted EPS in the first full year following completion and double‐digit accretive by year 3.

LabCorp explores acquisition of clinical trials firm PPD

Laboratory Corporation of America Holdings (LabCorp) is in talks to acquire contract researcher Pharmaceutical Product Development LLC (PPD) for more than $8 billion, including debt, people familiar with the matter said on Friday. Such a deal would be LabCorp’s largest acquisition ever, advancing its strategy of combining laboratory testing services under one corporate umbrella following its acquisition of contract research organization Covance Inc in 2015 for $5.7 billion.

Ferring collaborates with Foresee to use the latter’s controlled-release tech

Ferring Pharmaceuticals has struck a deal with Foresee Pharmaceuticals. The agreement will see Ferring fund development of a long-duration peptide drug based on Foresee’s delivery technology and potentially pick up the resulting asset if it meets expectations. Foresee has landed the deal on the strength of its stabilized injectable formulation (SIF) platform, a technology the Taiwanese drugmaker developed to enable controlled-release delivery of peptides, small molecules and proteins. Ferring penned a deal to use the technology to create a formulation of an as-yet-unidentified peptide after assessing the progress made by Foresee to date.

Johnson & Johnson Licenses its HIF portfolio to Akebia

Johnson & Johnson has outlicensed its portfolio of hypoxia-inducible factor (HIF) to Cambridge MA-based Akebia as the biotech boosts its early-stage pipeline. On top of this, Johnson & Johnson’s Innovation unit (aka JJDC) has also written in a clause for it to “take an ownership interest” in Akebia through a common stock purchase warrant for 509,611 shares. This can be used by JJDC, in whole or in part, at any point over the next five years with a payment to Akebia of up to $5 million. The first part of the deal, which sees the biotech cough up $1 million to J&J, also sees the biotech gain access to a library of HIF pathway compounds, which it says in a statement has the potential to be used across “multiple therapeutic areas.”

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AMRI enters alliance with Bruker Daltonics and HighRes Biosolutions

AMRI has entered an alliance with Bruker Daltonics and HighRes Biosolutions to develop new applications for using high throughput mass spectrometry (MS) for drug discovery. AMRI has acquired the new MALDI PharmaPulse system from Bruker Daltonics and HighRes Biosolutions. The system will be deployed at AMRI’s Integrated Drug Discovery Center and, in accordance with the terms of the alliance, Bruker Daltonics and HighRes Biosolutions will provide training and consulting to AMRI biologists to aid them in their development of protocols on the system that can be used for high throughput screening drug discovery programs.

Ferring Pharmaceuticals and Enteris BioPharma enter into a license agreement

Ferring Pharmaceuticals and Enteris BioPharma have entered into a license agreement and initiated an early development agreement to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence, to engineer an oral formulation of a peptide-based injectable therapeutic developed by Ferring. Enteris will license to Ferring its oral drug delivery technologies, as well as provide clinical trial finished product, and will receive milestones and royalties based on net sales of the developed product.

Quotient Clinical Acquires SeaView Research

Quotient Clinical has acquired SeaView Research with the aim of expanding its operations into the U.S. The acquisition combines Quotient and SeaView’s complementary customer portfolios, and strengthens the early phase clinical experience of the combined business, enabling the company to deliver a broader set of services. Each of the facilities is capable of undertaking complex clinical research studies including first-in-human investigations.

Renova takes over Rights of stresscopin from Janssen

Renova Therapeutics, gene therapy specialist, has signed an agreement to receive the investigational new drug (IND) file for stresscopin from Janssen Pharmaceuticals. Stresscopin is a hormone involved in responses to physiological stress and was previously under development at Janssen. Stresscopin has been shown in preclinical studies to protect cells exposed to fluctuating oxygen levels, such as occur in the heart in cardiovascular disease. Janssen’s scientists had previously shown that stresscopin and other related peptides can increase the ability of heart cells to contract. Renova will advance the programme development as RT-400, a peptide infusion treatment for episodes of acute decompensated heart failure (ADHF), which accounts for about half of all heart failure-related causes of hospitalization in the US.

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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.

 

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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.

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With Flublok at a standstill in Japan, Astellas ditches collaborator UMN Pharma

After Japanese regulators turned away the partners’ submission for a new cell-culture flu vaccine, Astellas has pulled the plug on a collaboration with UMN Pharma. UMN said it’s “regrettable” the companies can no longer work together to push the vaccine, Protein Sciences’ Flublok, to the market in Japan. The pharmas first linked up back in 2010. The shot had previously met its endpoints in a phase 3 trial, according to a release from UMN, and development partner Astellas submitted a marketing application to Japanese health authorities in May 2014. The Pharmaceuticals and Medical Devices Agency considered the risks and benefits, and notified Astellas that it would not further conduct its review; Astellas moved to withdraw the app.

Deal-talkers J&J, Actelion reportedly land on a price, but spinoff details still pending

Johnson & Johnson and Actelion may have finally settled a key condition of their long-discussed transaction. The pair has landed on a price for the deal, although sources didn’t tell what that price was. J&J was considering a price in the $260-per-share range for Actelion’s marketed meds, a figure that would bring the buy to more than $28 billion. J&J’s courtship of the Swiss biotech has been a long one, in part thanks to Actelion founder and CEO Jean-Paul Clozel’s desire to keep a piece of his company flying solo.

To win Trump’s deal backing, Bayer made a new $8B-plus pledge.

Bayer’s $66 billion Monsanto takeover has plenty of critics. But thanks to an $8 billion R&D pledge, it has one key backer: U.S. President-elect Donald Trump. Bayer and Monsanto said that their respective CEOs—Werner Baumann and Hugh Grant—had a “very productive” meeting with Trump and his team, resulting in a pledge to promise $16 billion or more in agriculture R&D over the next six years, with at least half of that coming in the U.S.

Biogen to fork over $1.25B-plus to settle blockbuster Tecfidera patent fight with Forward

Biogen has settled its Tecfidera patent fight with Forward Pharma for a whopping $1.25 billion in upfront cash. And if Forward wins particular patent rights on its rival drug, Biogen will be on the hook for Tecfidera royalties of at least 10%. Forward shares skyrocketed 83% to a $33.28 high in premarket trading on Tuesday after Biogen announced the deal. Although the companies still have issues to resolve, the agreement gives Biogen a license to all of Forward’s related intellectual property, and it grants the Danish company potential royalties on Tecfidera, a product that brought in nearly $2.4 billion in sales in the first nine months of 2016 alone. Forward is developing a potential Tecfidera competitor now dubbed FP187.

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With $496M CNS sale, Novartis joins other Pharma companies casting off tired meds

The latest Big Pharma to join the asset-sale party is Novartis, which is in talks to offload some of its older central nervous system (CNS) drugs, including Ritalin for attention deficit disorder and Exelon patch for Alzheimer’s. The portfolio could bring in as much as $496 million, and potential buyers include Endo, Mallinckrodt and generic drug makers. Novartis is far from the only company thinking along those lines. AstraZeneca, in fact, has turned asset selling into a cottage industry, casting off the international rights to two heart-disease drugs for $500 million earlier this year, and before that raising nearly $1 billion in a string of out-licensing deals.

Sanofi weighs Actelion offer to compete with J&J’s $27B

Reports are floating around claiming that Sanofi is offering up to $27 billion to a so-far unresponsive Actelion that is being pursued by J&J. Sources claim that Sanofi is weighing a counterbid, which presumably would have to top $27 billion. Sanofi is working with financial advisers on a potential offer, and it has told Actelion that it’s interested. It hasn’t yet made a formal move or even decided whether to make an offer, However. Sanofi hasn’t yet commented on the reports. J&J is said to be aiming to strike a deal before Christmas, so the process could move quickly from here if nothing else happens. And with a $27 billion price tag, among the largest of 2016, Actelion will be a closely watched target along the way.

Valeant and Takeda’s $10B Salix deal talks scuttled by price squabbles

Talks have broken down at the last minute because of disagreements over price for Valeant’s $10 billion plan to sell its Salix business to Takeda. Takeda, which has reportedly tried multiple times to get its hands on Salix—first as a bidder in the auction Valeant eventually won, and earlier this year with an offer to buy the whole Valeant company—wanted to shell out a lower sum for the GI business. The portfolio has underperformed lately, as many of Valeant’s key meds have, compounding the problems of a company that’s already faced channel-stuffing allegations, a slew of investigations, political pricing pushback and debt-default worries from investors. While there’s still a chance talks could be restarted, Valeant has already decided to move forward with plans to build Salix up on its own—and it’s already announced some of those plans to the public, too.

Astellas scouts pipeline buys for post-Xtandi future

Having built a fortune on a lucrative Xtandi partnering deal, Astellas is scouting for a new round of assets to deliver growth in its next chapter. The Japanese drug maker is joining the likes of larger companies such as Gilead, Johnson & Johnson and Sanofi in biopharma’s active M&A arena. Astellas is scouting for buys in immuno-oncology, Bloomberg reported, and has identified muscular diseases and ophthalmology as potential expansion areas. It’s also working to refocus and sell assets that aren’t central to its plans. Facing a 2019 patent cliff, Astellas has about $3.6 billion in cash to help finance one or more acquisitions.

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Novartis eyes $8B Amneal buy

Novartis is weighing a deal for the generics maker Amneal Pharmaceuticals to expand its already-hefty Sandoz unit, at a time when two of its biggest rivals in the field are integrating big buyouts of their own. The Amneal buy could be worth up to $8 billion. Joerg Reinhardt, chairman of the Swiss drug maker, made the broadest suggestion yet that Alcon’s days under Novartis’ umbrella are numbered. The ophthalmology unit has been struggling in recent quarters, and Reinhardt suggested that Alcon needs to recover soon, or face life under new ownership.

Pfizer considers cashing in on its consumer health business

Rumour mills are going abuzz with the news that Pfizer is considering doing something with its consumer health operations and that it could bring in around $14 billion. However, there is no indication whether Pfizer is thinking of a sale, or a tax-free spinoff like it used for its animal health unit Zoetis, or some kind of an asset swap.

Mylan pushes to seal $465M settlement as it posts a Q3 loss

Mylan executives are working to finalize a $465 million settlement with the federal government for Medicaid overcharges. The deal would see Mylan admit no responsibility but resolve allegations that the company misclassified its big-selling epinephrine injector as a generic. CEO Heather Bresch told analysts on Wednesday that the company is looking for bolt-on deals rather than a big acquisition.

Valeant in talk with Takeda for $10B Salix deal

The Canadian pharma is in advanced talks to sell its Salix gastrointestinal unit to Takeda for about $10 billion. Valeant had acquired Salix just a year and a half ago for about $11 billion, beating out interested suitors Shire and Endo. Meanwhile, the deal-talks news put Valeant shares on the rise just after word of the accounting fraud sent them to their lowest depths since 2010.

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Cancer Research UK and Cancer Research Technology to collaborate with TYG Oncology

Cancer Research UK and Cancer Research Technology (CRT), the charity’s commercial arm, have signed an agreement with TYG oncology (TYG) to take its TYG100, a new antigen-specific, active checkpoint control cancer vaccine, into clinical trials involving cancer patients with advanced solid tumours.TYG100 is a new treatment using a patient’s own immune system to target hormones that encourage the growth and spread of solid tumours. This vaccine works by triggering the production of antibodies that particularly target two members of the gastrin hormone family, which fuel tumour growth.

GE Healthcare and Valneva collaboration results in cell culture medium for vaccine production

GE Healthcare’s Life Sciences business and integrated vaccine biotech company, Valneva SE, has successfully collaborated to optimize virus productivity in Valneva’s EB66 cell-line, a proprietary technology for the production of a wide variety of vaccines, including human and animal health. Viral production in EB66 cells includes secreted viruses, such as measles, alphaviruses, influenza A and B strains, and intracellular viruses, such as the modified vaccinia Ankara (MVA) virus. This collaboration has led to the creation of a commercial cell culture medium, HyClone CDM4Avian, developed to address the challenges of media variability.

UPS to Acquire Marken

UPS has entered into a definitive agreement to acquire Marken, a global provider of supply chain services to the life sciences industry. The transaction, subject to customary closing conditions, is expected to close by December 31. Financial details and terms were not disclosed. Marken operates a global network of clinical supply chain services to meet increasingly complex regulatory compliance demands for clients. UPS has been expanding its healthcare logistics services portfolio through several recent acquisitions.

Asymchem Laboratories, Xbrane Biopharma, Biohaven Pharmaceutical Holding Company

Chinese-based contract manufacturing company Asymchem Laboratories has announced the issue of shares of its common stock in an initial public offering (IPO). The financial details of the IPO are yet to be disclosed. An exclusive, non-binding distribution agreement has been signed by Swedish biopharma company, Xbrane Biopharma, with a Chinese pharmaceutical company to sell and market the former’s product Spherotide in China. The drug is scheduled to be launched in 2021 and is estimated to have the potential to generate $38.8min annual revenue.

 

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Medivir entered into an agreement with Karo Pharma to sell its subsidiary BioPhausia

Medivir is set to sell is subsidiary, BioPhausia, to Karo Pharmafor for Skr908m ($100.9m). The agreement shows that this price will be on a cash and debt free basis, including a normalized working capital, with the transaction expected to close by mid-December. BioPhausia comprises 13 established pharmaceutical drugs. From the third quarter of 2015 to the second quarter of 2016, BioPhausia posted revenues of Skr189m ($21m).

Astellas to acquire German company Ganymed Pharmaceuticals

Japan’s Astellas Pharma has signed an agreement to acquire German-based biopharmaceutical company Ganymed Pharmaceuticals for €1.2bn. With this transaction, Astellas will be able to continue to build upon its oncology franchise as a platform for sustainable growth. Under the agreement, Astellas will initially pay €422m to acquire 100% stake in Ganymed and Ganymed’s shareholders will subsequently receive up to €860m based on progress in the IMAB362 clinical programme development.

Celldex Acquires Kolltan Pharmaceuticals

Celldex Therapeutics has entered into a definitive agreement to acquire Kolltan Pharmaceuticals, a clinical-stage company focused on the discovery and development of antibody-based drugs targeting receptor tyrosine kinases (RTKs), primarily in oncology. Clinical data has shown that Kolltan’s drug candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors. Celldex believes Kolltan’s drug candidates and preclinical platform are compatible with the company’s scientific approach and can be developed independently and in combination with Celldex’s existing product candidates.

Allergan to Acquire Motus Therapeutics

Further building its gastrointestinal (GI) disease portfolio, Allergan plans to acquire Motus Therapeutics (formerly Rhythm Health), the GI-focused, wholly owned subsidiary of Rhythm Holding, for $200 million upfront plus an undisclosed sales milestone payment. The acquisition is the third in 5 weeks through which Allergan has expanded its GI offerings. Allergan had previously started plans to acquire Tobira Therapeutics for $1.695 billion and Akarna Therapeutics for $50 million. This acquisition is Allergan’s third, which includes Motus’ lead drug candidate, relamorelin (RM-131), a ghrelin agonist being developed for diabetic gastroparesis.