Eisai/Merck & Co’s Lenvima approved in EU for first line liver cancer

The European Commission has approved Eisai/Merck & Co’s Lenvima as a new first-line treatment for liver cancer.

Eisai and Merck & Co, known as MSD outside the US, said approval for Lenvima (lenvatinib) came through an open-label phase 3 trial, REFLECT, demonstrating a treatment effect on overall survival (OS). It was deemed non-inferior to the standard of care drug, Nexavar (sorafenib).

Also, the trial results confirmed that Lenvima showed a significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR) in adults with previously untreated unresectable hepatocellular carcinoma.

Those treated with Lenvima experienced a median OS of 13.6 months compared to 12.3 months with sorafenib. The median PFS was 7.3 months versus 3.6 months.

The drug is an oral receptor tyrosine kinase (RTK) inhibitor, which works by disrupting the behaviour of cancer cells.

Gary Hendler, chairman and CEO, Eisai EMEA, said, “Patients with hepatocellular carcinoma are faced with a cancer that is difficult to treat and has a particularly poor prognosis, with only one systemic first-line treatment option currently available.

“Lenvatinib is the first new treatment option to be made available in this first-line systemic treatment setting in over a decade and represents an important new therapeutic option for patients. Eisai and Merck are therefore committed to working together to ensure that patients have rapid access to lenvatinib across Europe.”

Liver cancer kills around 750,000 people a year worldwide with 69,000 of those in Europe. Hepatocellular carcinoma represents approximately 90% of primary liver cancer cases and surgery to remove the disease is often not possible.

Bayer’s Nexavar and Lenvima are currently the only drugs available as first-line treatments of patients with unresectable hepatocellular carcinoma. Lenvima is the only first-line treatment to be approved in Europe for this type of cancer for more than a decade.

The US Food and Drug Administration (FDA) approved Lenvima earlier this month, based on the REFLECT trial results.

https://bit.ly/2o7nLZF

China Biologic Updates on Unsolicited Acquisition Proposals, Private Placement

China Biologic Products Holdings, Inc. (NASDAQ: CBPO) (“China Biologic” or the “Company”), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company’s board of directors (the “Board”) has received a letter dated August 23, 2018 from CITIC Capital MB Investment Limited, an affiliate of CITIC Capital Holdings Limited (“CITIC”), withdrawing its preliminary non-binding proposal dated June 11, 2018, with immediate effect. The Company further announced that the Board has unanimously decided to reject the previously announced preliminary non-binding proposal dated August 17, 2018 from the consortium (the “Consortium”) consisting of Feng Tai Global Limited, a company beneficially owned by Mr. David (Xiaoying) Gao, the former Chairman and CEO of the Company, GL Sandrose Investment L.P., World Investments Limited and CDH Utopia Limited.

After careful review of the Consortium’s proposal, the Board has unanimously determined that it is not in the best interests of the Company and its shareholders as it did not reflect the intrinsic value of the Company and would abrogate the shareholders’ opportunity to enjoy the long-term return from the Company’s execution of its business strategy of growing into a leading global biopharmaceutical company.

In addition, the Company announced that it has entered into definitive agreements (the “Share Purchase Agreements”) for the issuance and sale of an aggregate of 5,850,000 ordinary shares of the Company, which represents 14.9% of the enlarged share capital post the issuance and is expected to raise gross proceeds of approximately US$590 million. The Company intends to use such proceeds to support its business expansion plan and strategic acquisitions. Under the Share Purchase Agreements, Centurium Capital Management Ltd. (“Centurium”), CITIC, Hillhouse Capital Management, Ltd. (“Hillhouse”), each via its respective investment vehicle(s), and PW Medtech Group Limited (“PWM”, and together with Centurium, CITIC and Hillhouse, the “Investors”) will subscribe for and purchase 3,050,000, 1,000,000, 1,000,000 and 800,000, respectively, newly issued ordinary shares of the Company at a per share purchase price of US$100.90, representing the closing price per share as quoted by the NASDAQ Global Market on August 23, 2018, and a premium of 2.5% and 7.9%, respectively, over the Company’s 30 and 90 trading day volume weighted average price as quoted by the NASDAQ Global Market through August 23, 2018.

The closings of the transactions are subject to customary conditions, and the first tranche consisting of an aggregate of US$383.42 million investment from Centurium, CITIC and Hillhouse is expected to close today. The rest of the investment is expected to close within 30 days from today. Upon the consummation of all the closings, Centurium, CITIC, Hillhouse and PWM will beneficially own approximately 7.76%, 6.82%, 6.63% and 16.08% of the Company’s total outstanding shares, respectively. In connection with the subscription for the new shares, each of the Investors has agreed to certain transfer restrictions, including a two-year lockup of the shares acquired in this transaction, transfer restrictions with respect to the Company’s competitors, and voting agreement in accordance with the Board’s recommendations at the Company’s shareholders’ meetings.

Centurium is affiliated with two directors of the Board, Mr. David Hui Li and Mr. Joseph Chow, and PWM is the single largest shareholder of the Company with a director representative, Ms. Yue’e Zhang, on the Board. Therefore, the Board formed a special committee consisting of two independent directors, Dr. Yungang Lu and Mr. Qi Ning to negotiate and evaluate the Share Purchase Agreements and the transactions contemplated thereby. After careful deliberation and upon the recommendation of the special committee, the Board with the affiliated directors abstaining from deliberating and voting, unanimously approved the Share Purchase Agreements and the transactions contemplated thereby.

“We are delighted to be partnering with this group of highly respected and experienced investors to accompany China Biologic as we grow and evolve into a world leading biopharmaceutical company,” said Dr. Bing Li, CEO of China Biologic. “Through the additional capital and strategic partnerships gained through this private placement, China Biologic will be very well situated to acquire and develop the leading technologies and assets that will help drive exceptional shareholder value for the long term. I am confident that we now have the right management team, strategy, and committed investor base to fully realize China Biologic’s potential as an industry leader.”

https://bit.ly/2P2Vsqp

Zogenix recent pullback a buying opportunity, says Mizuho

Mizuho analyst Difei Yang views the recent selloff in shares of Zogenix as a buying opportunity. The analyst believes ZX008 in Lennox-Gastaut syndrom presents upside potential in 2019 and that Zogenix “is in comfortable position” to reach break-even following a recent $359M capital raise. Yang reiterates a Buy rating on the shares with a $69 price target.

https://bit.ly/2Nh3CeC

Tandem Diabetes upgraded to Neutral, target to $45 from $2 at BofA/Merrill

BofA/Merrill analyst Travis Steed upgraded Tandem Diabetes to Neutral from Underperform and raised its price target to $45 from $2. Steed is no longer concerned about the balance sheet and believes the company has a multi-year window with a superior product that will driver 20-30% growth, but most of these tailwinds are reflected in valuation. The analyst said pump renewals are becoming a contributor and Tandem is moving into international markets, offsetting the Animas void.

https://bit.ly/2MsPceO

Mallinckrodt price target raised to $37 from $20 at B. Riley FBR

B. Riley FBR analyst David Buck raised his price target for Mallinckrodt to $37 but keeps a Neutral rating on the shares.

https://bit.ly/2Mz9vYl

General Mills changing Nature Valley labels after lawsuit’s pesticide claim

 General Mills Inc agreed to stop calling the oats in its Nature Valley granola bars 100 percent natural to settle a lawsuit by three consumer groups that said the bars contained small amounts of the pesticide commonly known as Roundup.

Beyond Pesticides, Moms Across America and the Organic Consumers Association on Thursday said the settlement calls for General Mills to remove the phrase “Made with 100% Natural Whole Grain Oats” from Nature Valley labels.

The groups said independent tests showed that the granola bars contained 0.45 parts per million of glyphosate, and that oats were the “most likely” source of the pesticide.

While this was below the maximum 30 parts per million that the U.S. Environmental Protection Agency recommends, the groups said General Mills’ label was deceptive and that “no reasonable consumer” would expect the bars to contain anything unnatural.

“Nature Valley is confident in the accuracy of its label,” General Mills spokesman Mike Siemienas said in an email.

He said the Minneapolis-based company settled to avoid the cost and distraction of litigation, and focus on making Nature Valley products “with 100 percent whole grain oats.”

The settlement came 13 days after a San Francisco jury ordered Monsanto Co to pay a school groundskeeper $289 million after he said his exposure to its Roundup weed killer and another glyphosate herbicide caused his non-Hodgkin’s lymphoma.

Bayer, which now owns Monsanto, has said it would appeal the jury’s verdict.

The General Mills lawsuit was one of many accusing food companies of using deceptive labels, including terms such as “natural” that do not have clearly understood meanings, to induce consumers to buy or pay more for their products.

In July 2017, a Minneapolis federal judge dismissed a proposed class action lawsuit over General Mills’ “100% Natural” label, saying that even if the oats contained traces of glyphosate, “there is no allegation that the oats, themselves, are not natural.”

A subsequent appeal was dismissed.

The consumer groups had sued General Mills two years ago in Superior Court in Washington, D.C.

The Organic Consumers Association sued Unilever Plc in the same court on July 9 over its labeling for Ben & Jerry’s ice cream, including a claim over the use of glyphosate.

https://bit.ly/2OXzXaD

FDA Bans E-Cig Liquid Products That Look Like Snacks, Candies

Potentially poisonous electronic cigarette liquid (e-liquid) made by 17 different manufacturers comes in packaging that strongly resembles that of candies, cookies, and other snacks popular with children.

And after warnings sent to the companies in May, the U.S. Food and Drug Administration banned the products on Thursday. The agency told the companies that labels and ads for the nicotine-containing e-liquids were false or misleading, and potentially dangerous. In addition, several of the companies were previously cited for illegally selling the products to minors, the FDA said.

Examples of the products targeted in the warning letters included: One Mad Hit Juice Box, which resembled children’s apple juice boxes; Whip’d Strawberry, which resembled a dairy whipped topping; Twirly Pop, which resembled a Unicorn Pop lollipop and was shipped with one; and Unicorn Cakes, which included images of a strawberry beverage and unicorns eating pancakes, similar to those used by the My Little Pony television and toy franchise.

“When companies market these products using imagery that misleads a child into thinking they’re things they’ve consumed before, like a juice box or candy, that can create an imminent risk of harm to a child who may confuse the product for something safe and familiar,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “We’re committed to holding industry accountable to ensure these products aren’t being marketed to, sold to, or used by kids.”

FDA Press Release
More Information

https://bit.ly/2OVM87G