On February 4, 2021 Bayer AG reported a $2 billion deal to resolve future legal claims that its widely used weedkiller Roundup causes cancer, the German company said on Wednesday (Press release, Bayer, FEB 4, 2021, View Source [SID1234574704]).

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Bayer has been struggling to finalize the settlement of claims that Roundup and other glyphosate-based herbicides cause non-Hodgkin’s lymphoma, a type of cancer. Bayer inherited the business and the litigation as part of a $63 billion acquisition of Monsanto in 2018.

The company has said that decades of studies have shown Roundup and glyphosate are safe for human use.

Wednesday’s settlement would cover future claims brought by individuals who have been diagnosed with non-Hodgkin’s lymphoma and were exposed to Roundup before their diagnosis. The settlement also includes benefits for people who were exposed to Roundup and develop the cancer in the future.

Roundup, which Monsanto first brought to the market in 1974, is widely used by farmers across the United States and Brazil, alongside crops that are genetically engineered to withstand the its herbicidal effect.

Glyphosate will remain on the market. Bayer agreed to seek permission from the U.S. Environmental Protection Agency to provide a reference link on labels so consumers can find scientific studies on the weedkiller.

Under the proposed plan, Bayer will provide $2 billion for a four-year period as compensation and to cover outreach and diagnostic assistance. Future claimants could receive up to $200,000 under the deal.

The parties can agree to extend the settlement period.

The company said the settlement amount was disclosed last year.

The agreement must be approved by U.S. District Court Judge Vince Chhabria in San Francisco.

Chhabria in June questioned the legality of a prior settlement plan that Bayer proposed, which envisioned creating a panel of scientists who would rule on the viability of claims.

Under the revised deal, anyone who does not make a claim during the four-year period would then be able to sue in court, according Elizabeth Cabraser, an attorney for the proposed class. She also said anyone diagnosed with non-Hodgkin’s lymphoma who does not like their compensation offer under the class plan can go to the court system and try for a better result.

In June, Bayer reached a wider $9.6 billion settlement that would resolve the bulk of the more than 100,000 U.S. lawsuits that were already filed over Roundup.

Bayer’s stock has been battered by the litigation, but also by billions of euros in writedowns, and a bleaker profit outlook, in large part related to the $63 billion Monsanto takeover.

The group last year announced 9.25 billion euros in impairment charges on agricultural assets and shocked markets by predicting a slight decline in core earnings per share in 2021 on weaker demand by farmers.

On February 4, 2021 Novartis reported that may have jumped out ahead of Merck KGaA with targeted lung cancer med Tabrecta, but the German drugmaker has evened the score (Press release, Merck KGaA, FEB 4, 2021, View Source [SID1234574703]).

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The FDA Wednesday cleared its drug Tepmetko in non-small cell lung cancer patients with MET exon 14 skipping mutations, whether or not they’ve received prior treatments. The mutation affects about 3% to 4% of NSCLC patients and creates an aggressive form of the disease.

Tepmetko will bear a list price of $20,898.60 for a 30-day supply, which is "within the range of other oral oncolytics for advanced NSCLC," a spokesperson said by email.

U.S. regulators based their decision on data from the phase 2 Vision trial, which showed Tepmetko could spur a benefit in 43% of patients. Previously treated patients continued to respond to the drug for a median 11.1 months, while those new to therapy responded for a median 10.8 months.

RELATED: Merck KGaA beats out Novartis with targeted lung cancer nod for Tepmetko in Japan

The FDA’s nod follows up on a positive decision from the Japanese Ministry of Health, Labour and Welfare, which last March became the first global regulator to green-light a MET inhibitor. Since then, though, the FDA has gotten in on the action with its May 2020 go-ahead for Tabrecta, and now Merck will be taking its product toe-to-toe with Novartis’ in the U.S.

While the Swiss pharma giant has the head start, Merck KGaA has its own advantage to tout: once-daily dosing. Tabrecta tablets are given twice daily at a 400 mg dose, while patients take two 225 mg Tepmetko tablets simultaneously just once per day.

"Our focus now is to ensure Tepmetko is accessible to patients in the United States and fully integrated into clinical practice, given the important advance it represents for indicated patients as an oral once-a-day precision medicine," said Danny Bar-Zohar, M.D., global head of development for Merck KGaA’s healthcare business.

RELATED: Novartis beats Merck KGaA to U.S. finish line with targeted lung cancer drug Tabrecta

To do that, though, first Merck KGaA will have to ramp up MET testing—a goal Novartis shares. Testing for the mutation is usually done as part of next-gen lung cancer sequencing, Ameet Mallik, EVP at Novartis Oncology U.S., said an interview last spring, and at that time, only about 35% of U.S. lung cancer patients were receiving that sequencing upfront.

On February 4, 2021 Shanghai Fosun Long March Medical Science Co., Ltd. (Fosun Long March) reported that it has executed a non-binding Letter of Intent (LOI) with bioAffinity Technologies, Inc. providing for Fosun to evaluate CyPath Lung, a non-invasive test for the early detection of lung cancer, with an expectation of negotiating and entering into binding agreements to commercialize the early lung cancer diagnostic in China (Press release, BioAffinity Technologies, FEB 4, 2021, View Source [SID1234574691]).

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Fosun Long March is a high-tech in-vitro diagnostics enterprise active in manufacturing, marketing, and research and development of diagnostic and laboratory instruments and reagents. Fosun Long March is a wholly owned company of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, stock code: 02196.HK; 600196.SH). Fosun Pharma is a leading healthcare company in China and is listed on the Shanghai Stock Exchange and on the Main Board of the Hong Kong Stock Exchange.

Dr. Yuejian Zhang, Chief Executive Officer of Fosun Long March, said, "We are impressed with the results of the CyPath Lung test validation trial that showed high accuracy in detecting lung cancer in people at high risk for the world’s most deadly cancer. CyPath Lung is patient-friendly and reasonably priced, making it a good fit in the China market. The test could make a very positive impact. Whilst China represents a little under 20% of the world’s population, it accounts for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2020, of which 18% are due to lung cancer. We look forward to proceeding with the collaboration with bioAffinity Technologies and working together to launch CyPath Lung in China."

Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies, said, "Fosun Long March is a driving force in healthcare, bringing medical breakthroughs to China and the world that improve the health and clinical outcomes of patients. We are very excited to be working with Fosun Long March in advancing CyPath Lung. China represents a $5 billion market for CyPath Lung. An estimated 780,000 people will be diagnosed with lung cancer annually in China, most often at late stage. CyPath Lung is proven to detect lung cancer at early stages, providing opportunities for more effective and less caustic treatments that can save lives."

Ms. Zannes continued, "CyPath Lung offers a simple, cost-effective and highly accurate test. Patients collect their sputum samples at home, a significant benefit during this time of COVID-19 that will last well after the pandemic subsides. Samples are processed at a central laboratory including use of a proprietary porphyrin that labels cancer. Single-cell analysis is performed at extraordinary speed by flow cytometry and data fed through our automated AI-designed platform to provide physicians with results in minutes. CyPath Lung showed 92% sensitivity and 87% specificity in detecting lung cancer in high-risk, heavy smokers who had lung nodules smaller than 2 cm or no nodules in the lung. The detection of small lung nodules in people who have early stage cancer can dramatically increase lung cancer survival."

On February 4, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage immuno-oncology company, reported the pricing of its upsized initial public offering of 11,500,000 shares of common stock at a price to the public of $20.00 per share (Press release, Bolt Biotherapeutics, FEB 4, 2021, View Source [SID1234574677]). In addition, Bolt has granted the underwriters a 30-day option to purchase up to an additional 1,725,000 shares of common stock solely to cover over-allotments, if any, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the symbol "BOLT" on February 5, 2021.

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Morgan Stanley, SVB Leerink, Stifel and Guggenheim Securities are acting as joint bookrunners for the offering.

The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105 or by email at [email protected].

Registration statements relating to these securities have been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 4, 2021 Veracyte, Inc. (Nasdaq: VCYT) (the "Company") reported the pricing of an underwritten public offering of 7,432,433 shares of its common stock at a public offering price of $74.00 per share (Press release, Veracyte, FEB 4, 2021, View Source [SID1234574670]). The gross proceeds to the Company from this offering, before deducting underwriting discounts and commissions and offering expenses payable by Veracyte, are expected to be approximately $550 million. The public offering was upsized from the previously announced size of $400 million in shares of common stock. All of the shares are being offered by the Company. The offering is expected to close on or about February 9, 2021, subject to customary closing conditions. In addition, the Company granted to the underwriters participating in the offering a 30-day option to purchase up to an additional 1,114,864 shares of its common stock at the public offering price, less underwriting discounts and commissions.

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Veracyte intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to finance its acquisition of Decipher Biosciences, Inc. Veracyte intends to use the remaining net proceeds of this offering for working capital and other general corporate purposes, which may include acquisitions or investments in complementary businesses, technologies or other assets, although it has no present commitments or agreements to do so (other than with respect to Decipher Biosciences, Inc.).

Goldman Sachs & Co. LLC and SVB Leerink LLC are acting as joint lead book-running managers for the offering, William Blair & Company, L.L.C. is acting as a book-running manager and BTIG, LLC, Needham & Company, LLC, and Lake Street Capital Markets, LLC are acting as co-managers.

The shares will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (the "SEC") on February 3, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. A copy of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected], or by telephone at (866) 471-2526; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at [email protected], or by telephone at (800) 808-7525, ext. 6105.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Veracyte, Afirma, Percepta, Envisia, Prosigna, LymphMark, and Know by Design, and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are trademarks of Veracyte, Inc.