Lilly joins forces with NextCure to fuel immuno-oncology expansion

Eli Lilly has teamed up with NextCure to continue its immuno-oncology expansion. The deal gives Lilly a source of antibodies against novel cancer targets in return for $25 million upfront and undisclosed milestones.

Lilly spent the first stage of the immuno-oncology era on the sidelines but this year has shown signs that it is ready to enter the fray. A new-look immuno-oncology team is in place, and the $1.6 billion takeover of Armo Biosciences has given it a phase 3 PEGylated IL-10 and a clutch of early-stage drugs to push through the clinic.

The NextCure agreement could bolster Lilly’s early-stage immuno-oncology pipeline. NextCure, which is staffed by executives who led Amplimmune to a takeover by AstraZeneca, is built upon a platform for scouring cell surface interactions in search of targets that affect immune function.

Lilly is paying $25 million upfront and taking a $15 million stake in NextCure for the chance to access the fruits of the platform. In return, Lilly gets an option to exclusively license antibodies against targets discovered using NextCure’s platform. NextCure has the option to license antibodies, too, and will receive milestones and royalties of undisclosed size if the drugs Lilly picks up progress.

If the collaboration plays out as hoped, the drugs Lilly picks up will have the sort of standout features the Big Pharma will need to come from behind and claim a sizable slice of the immuno-oncology market.

“Through this collaboration, we hope to leverage NextCure’s discovery platform to expand the reach of this class of groundbreaking treatments by identifying novel cancer targets that could enable the development of a new generation of immuno-oncology therapies,” Lilly VP Greg Plowman said in a statement.

For NextCure, the agreement delivers cash and validation at an important moment for the company. Siglec-15 antibody NC318 recently moved into a phase 1/2 solid tumor trial, and a second candidate is due to get to the IND stage next year. NextCure last disclosed funding when it raised a $67 million series A at the start of 2016, and hired a CFO with IPO experience this April.

https://www.fiercebiotech.com/biotech/lilly-taps-nextcure-to-fuel-immuno-oncology-expansion

Need alternative funding? Perceptive Advisors has $675M for deals

The global tide of capital gushing into biopharma isn’t just going through traditional venture funds. As Perceptive Advisors is showing with their $675 million fund closed today, an increasing array of financing options are opening up to small- and mid-sized biotechs.

This is Perceptive’s second Credit Opportunities Fund, designed to provide “customized, minimally-dilutive debt financing solutions” ranging from $10 to $100 million per investment.

Like Fund I from 2016 — which totaled $323 million and capped each deal at $50 million — Fund II will open its doors to all kinds of healthcare companies, from biopharma and diagnostics to medical devices, life science research and information technology.

“We are continuing to see strong interest from healthcare companies seeking alternative funding solutions to enable growth and expansionary R&D opportunities,” said Sam Chawla, portfolio manager of Perceptive’s Credit Opportunities Funds.

Previous beneficiaries of the fund include specialty pharma Aquestive Therapeutics and VBI Vaccines, both of which negotiated senior debt facilities with warrants from Perceptive to finance R&D.

The money in this new fund comes from “a globally diverse group of institutional investors, including foundations, endowments, family offices, financial institutions and pension funds,” Perceptive says, contributing to an oversubscribed round.

https://endpts.com/need-alternative-funding-channels-perceptive-advisors-now-has-675m-devoted-to-those-deals/

Allergan Backs off From $200 Million Plant Expansion in Waco, Texas

Dublin-based Allergan announced in 2016 plans to spend $200 million to expand its manufacturing facility in Waco, Texas. That plan would have increased production capacity by more than 50 percent and created more than 100 jobs in the area.

The plant in Waco manufactures Allergan’s Restasis (cyclosporine ophthalmic emulsion) for dry eyes. It is Allergan’s second best-selling drug, but the company expects it to face some tough competition in the near future after courts ruled against the company’s patent protections for the drug.

Allergan had signed a licensing deal about four years ago with the Saint Regis Mohawk Tribe in the U.S., hoping that tribal sovereignty would protect the patents, but the courts struck it down. No generics have won approval yet, but several companies have generic applications pending.

The patent scheme was perceived both legally and ethically as a cynical and blatant attempt to avoid U.S. patent laws. Although the company’s chief executive officer, Brent Saunders attempted to spin it as something being done to help the tribe, no one was buying that rationale, and neither did the courts.

Allergan sold the patent to the St. Regis Mohawk Indian Tribe in New York state for $15 million a year (where Allergan paid the tribe), and then leased it back for $13.5 million. The idea was the tribe’s sovereign immunity would shield it from patent challenges, which had been filed by Mylan, Teva Pharmaceutical and Akorn.

On July 20, a federal appeals court ruled that the tribe’s sovereign immunity didn’t protect it from inter partes review (IPR). The three-judge court ruled that IPR was more of an “agency enforcement action than a civil suit brought by a private party, and we conclude that tribal immunity is not implicated.”

In terms of the Waco plant, the facility produces several eye care products, including Restasis, Lumigan and Combigan.

Allergan indicated that it “has shifted [its] priority from expanding the Waco site to investing significantly in our existing operations.”

However, the company spokesperson said that Allergan “remains committed to our eye care business and operations in Waco.”

For example, Allergan has invested $180 million between 2015 and 2018 in improving the facilities. It is also planning to hire about 45 positions at that location. Those positions are currently open, and the company says it hopes to attract returning military veterans. It recently donated $125,000 to “Heroes Make America,” a career program sponsored by the National Association of Manufacturers. It offers training, certifications and assistant in securing college credit to veterans.

The expansion was to involve another 322,000 square feet. According to the Waco Tribune-Herald, Allergan is giving up $4 million in incentives.

Lisa Brown, Allergan spokeswoman, told the Waco Tribune-Herald, the company “has brought new formulations to the Waco site almost every year, including Refresh Repair, and we have plans to add new formulations currently in development.”

Allergan currently employs about 700 people in Waco. Tom Kelly, an economist with Baylor University, had projected that the Waco expansion would have boosted the Central Texas economy by $522 million during the first year of construction, with another $461 million annual economic impact following.

https://www.biospace.com/article/allergan-backs-off-from-200-million-plant-expansion-in-waco-texas/

Janssen Inks Deal With Korea’s Yuhan for Lung Cancer Med Valued at up to $1.25B

South Korea-based Yuhan Corporation inked a licensing deal with Janssen for a non-small cell lung cancer drug candidate called lazertinib that has the potential to be worth up to $1.25 billion, the company announced late Monday.

On Monday, Yuhan announced that it had struck the bargain with Janssen, a division of healthcare giant Johnson & Johnson. The U.S. biotech agreed to pay Yuhan $50 million in upfront money. The Korean company is eligible for significant milestone and royalty payments that, if all goes well and the drug earns regulatory approval, could amount to the total of $1.25 billion, Yuhan said in the announcement. Yuhan said that Janssen will be responsible for the development of lazertinib. The global pharma powerhouse will also be responsible for manufacturing and commercialization of the drug. Janssen’s commercial rights do not include Korea, which Yuhan retained, according to Yuhan’s announcement.

Yuhan’s lazertinib is a third-generation epidermal growth factor receptor tyrosine kinase (EGFR-TK) inhibitor that has the ability to penetrate the brain barrier. Yuhan believes that it has the potential to be a first-line therapy for treatment of NSCLC. Lazertinib is currently undergoing Phase I/II trials in Korea. Interim data has shown that lazertinib exhibited robust disease activity in patients with NSCLC with acquired resistance to EGFR-TKIs, with or without brain metastasis and was well-tolerated with low rates of Grade 3 or higher adverse events, the company said. These results indicate that lazertinib may offer the possibility of a wider therapeutic index, making it a potential best-in-class candidate as a combination regimen, Yuhan added in its announcement.

Janssen and Yuhan said they will work together on clinical trials evaluating lazertinib both as a monotherapy treatment and as a combination regimen. The trials are expected to begin in 2019.

“Yuhan is committed to developing Lazertinib as an effective treatment option for patients suffering from NSCLC. And Janssen, with strong scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission. We are excited to start this collaboration and dive into advancing this treatment regimen with a focus on improving the lives of people who suffer from lung cancer,” Jung Hee Lee, president and chief executive officer of Yuhan said in a statement.

The deal with Yuhan comes about a month after Janssen Biotech terminated its research and license deals with Aduro Biotech, which was researching various cancer treatments with its Listeria-based therapies.

https://www.biospace.com/article/janssen-inks-deal-with-korea-s-yuhan-for-nsclc-drug-valued-at-up-to-1-25-billion/

Sage Therapeutics pricing for Zulresso at a premium to Piper Jaffray estimate

Piper Jaffray analyst Danielle Brill, who maintained an Overweight rating and $206 price target on Sage Therapeutics shares, noted that the announced plans to price Zulresso at $25,000-$35,000 per course — should it be approved on its December 19 PDUFA date — which is at a premium to Piper’s estimated net pricing of $15,000. Brill also noted that the drug’s sales force has been hired, which includes ~130 reps, and ~50 patient support/access personnel, and she is awaiting final commercial details following PDUFA announcement.
https://thefly.com/landingPageNews.php?id=2818641

Regeneron operating performance, pipeline diversity seen in Q3, says Piper

Piper Jaffray analyst Christopher Raymond reiterates an Overweight rating and $450 price target on Regeneron’s shares following Q3 top- and bottom-line beats. The analyst notes that over the last five quarters including Q3, EPS has beaten consensus on average by 55c, consistently driven by top-line beats. Combining strong operational performance with continued pipeline maturation and commercial momentum, the analyst continues to like the setup and remains a buyer.
https://thefly.com/landingPageNews.php?id=2818651

Theravance to Sell Antibiotic to Cumberland Pharmaceuticals

Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma” or the “Company”) today announced the sale of its proprietary antibiotic, VIBATIV^® (telavancin), to Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on the delivery of high-quality prescription brands to improve patient care. Under the terms of the agreement, Cumberland will pay Theravance Biopharma a total of $25 million and tiered royalties of up to 20% on future US net product sales.

VIBATIV is a once-daily, injectable lipoglycopeptide antibiotic approved in the US for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the US for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of VIBATIV in treating patients whose pneumonia or skin infection is complicated by concurrent bacteremia.

“This transaction with Cumberland Pharmaceuticals allows Theravance Biopharma to sharpen our focus on our most important strategic priorities, including preparations for the potential launch of YUPELRI™ (revefenacin) in COPD, if approved, plus executing on key pipeline programs,” stated Rick E Winningham, chairman and chief executive officer at Theravance Biopharma. “VIBATIV plays an important role in the growing global battle against antibiotic resistance. As we continue our focus on important programs outside of the anti-infectives market, we determined that the product could be best supported by another party. We believe that Cumberland’s track record of successfully marketing and selling hospital-based products combined with VIBATIV’s existing base of hospital formulary inclusions positions them to drive commercial success for VIBATIV as a flagship product and ensures the important therapeutic benefits of VIBATIV reach as many patients as possible.”

“VIBATIV is a lifesaving treatment for certain difficult to treat infections, and we are honored to be selected to acquire and transition the brand to our existing hospital acute care infrastructure,” said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. “Our immediate plan for VIBATIV is to ensure a smooth transition of the product supply and medical support to current users of the brand. We will then launch our hospital promotion and medical initiatives to help ensure that the product is available to the patients who need it. We are very optimistic about the opportunity that VIBATIV will offer Cumberland.”

The transaction is expected to close in mid-November, pending satisfaction of customary closing conditions.

Theravance Biopharma will provide additional remarks on its previously-scheduled third quarter 2018 earnings call today at 5:00pm ET, and call information is available here.

https://www.marketscreener.com/CUMBERLAND-PHARMACEUTICAL-5498888/news/Cumberland-Pharmaceuticals-Theravance-Biopharma-Announces-Sale-of-VIBATIV-telavancin-to-Cumberl-27555730/