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Wednesday, August 16, 2023

Stada CEO Confirms Buyout Rumors, Sale Could Potentially Fetch $11B

 German generics developer Stada Arzneimittel is mulling over a potential $11 billion sale, though there are no concrete and definite plans yet, CEO Peter Goldschmidt confirmed Tuesday.

Goldschmidt made the statement to German-language publication Zeit Online, which was confirmed by a Stada spokersperson to Endpoints News. “From my point of view, our owners are in an orientation phase in which initial exploratory talks are taking place. I don’t expect a decision before 2024,” Goldschmidt said, according to a translation from the spokesperson.

Rumors of the potential sale first circulated earlier this month when Bloomberg, citing sources familiar with the matter, reported that Stada’s private equity owners were looking at their options for the company moving forward including a sale.

Bloomberg reported that Bain Capital and Cinven had started approaching banks “to pitch for roles on a possible transaction.” If a sale does push through, Stada could go for approximately $11 billion (€10 billion) or more, according to the sources, who requested to remain anonymous.

Bain and Cinven assumed ownership of Stada in 2017, when the investment firms dropped approximately $5.6 billion to buy nearly 63.9% of the drugmaker’s outstanding shares. As part of the takeover, Bain and Cinven committed to support Stada including “investment in organic growth and expansion through acquisitions,” according to Cinven’s news release at the time.

According to the Stada spokesperson, Bain and Cinven are considering a sale now because “it is common for financial investors to exit after five to six years.”

Also on Tuesday, Stada posted its most recent earnings report touting its “best half-year results to date” with double-digit sales and strong profit growth, which were driven by the robust performances of its consumer healthcare, specialty pharmaceuticals and generics businesses.

The company’s consumer healthcare vertical, Stada’s largest strategic segment, saw several launches and line extensions which contributed to a 19% adjusted increase in sales. Recent acquisitions, including the Sanofi brands Omnivit and Ompticrom eye drops, also factored into the growth of the consumer healthcare business.

Stada’s generics and specialty segments also performed well with adjusted sales advancing by 8% and 24%, respectively. In particular, the launches of the anticoagulant apixaban, the diabetes drug sitagliptin, the pain-reliever tapentadol and the anti-parasitic medicine permethrin contributed to Stada’s strong first-half results.


AN2 Therapeutics Sells $70.0 Million Underwritten Offering of Common at Premium

 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced the pricing of an underwritten offering of 7,777,778 shares of its common stock. The shares of common stock are being sold at a price of $9.00 per share, a premium from today’s closing price. Investors who have agreed to purchase shares in the offering include RA Capital Management, TCGX, Frazier Life Sciences, Marshall Wace, Adage Capital Partners LP, Avidity Partners, Janus Henderson Investors and Surveyor Capital (a Citadel company). The gross proceeds from the offering to AN2 are expected to be approximately $70.0 million, before deducting underwriting discounts and commissions and offering expenses. The offering is expected to close on or about August 18, 2023, subject to the satisfaction of customary closing conditions.

TD Cowen, Leerink Partners, and Evercore ISI are acting as book-runners for the offering. Oppenheimer & Co. is acting as lead manager for the offering.

The shares are being offered by the company pursuant to a Registration Statement on Form S-3 previously filed and declared effective by the SEC. A final prospectus supplement and the accompanying prospectus relating to the offering will also be filed with the SEC. These documents can be accessed for free through the SEC’s website at www.sec.gov.

https://finance.yahoo.com/news/an2-therapeutics-announces-pricing-70-024200181.html

bluebird: AdComm Will Not Be Scheduled for lovo-cel Gene Therapy for Sickle Cell Disease

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel). Lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease (SCD) with a proposed indication for patients ages 12 and older who have a history of vaso-occlusive events (VOEs). The Agency previously accepted the lovo-cel Biologics Licensing Application (BLA) for Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.

"Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease and represents the third lentiviral vector gene therapy that the Agency has reviewed from bluebird—giving us great confidence in the robustness and maturity of our BLA package," said Andrew Obenshain, chief executive officer, bluebird bio. "We remain focused on working with the Agency on its review in anticipation of a decision by the end of this year."

The BLA for lovo-cel is based on efficacy results from 36 patients in the HGB-206 study Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each. The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up, which is the longest follow-up of any gene therapy program for SCD.

The FDA previously granted lovo-cel orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation, and rare pediatric disease designation.

https://finance.yahoo.com/news/bluebird-bio-confirms-fda-communicated-110000837.html

MediciNova: New Patent for Treatment of Scleroderma and Systemic Sclerosis in Europe

 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced it has received a Decision to Grant from the European Patent Office for a new patent which covers MN-001 (tipelukast) for the treatment of scleroderma and/or systemic sclerosis.

This patent is expected to expire no earlier than June 2035. The allowed claims cover the use of MN-001 (tipelukast) for inhibiting or treating scleroderma and/or systemic sclerosis. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms. The allowed claims cover a wide range of doses and a range of different dosing frequencies.

https://finance.yahoo.com/news/medicinova-receives-patent-covering-mn-230000768.html

Seagen Phase 3 Trial of Combo Meets Primary Endpoint in HER2-Positive Metastatic Breast Cancer

 Seagen Inc. (Nasdaq: SGEN) today announced that the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®) met its primary endpoint of progression-free survival (PFS). Patients in the trial had unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and had received previous treatment with a taxane and trastuzumab.​ Overall survival (OS) data, a secondary endpoint, are not yet mature. Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals emerged for the combination.

https://finance.yahoo.com/news/seagen-phase-3-trial-tukysa-120000463.html

Strathspey Clarifying Statement Re Form 4 Filing for Holdings in AEON Biopharma

 The 7,380,394 AEON shares reflected in the Form 4 filed on August 14th were transferred to limited partners of Strathspey Crown

Strathspey Crown did not sell any AEON shares to the public as part of this transaction
All shares transferred to limited partners continue to be subject to restrictions on transfer under securities laws and a significant portion are also subject to a 12-month lockup expiring July 21, 2024 as provided in AEON’s bylaws

Strathspey Crown intends to file a Schedule 13D/A in the coming days to reflect the same transaction and show its remaining holdings of 2,031,773 AEON shares

https://finance.yahoo.com/news/strathspey-crown-holdings-group-llc-110000217.html

WTO Rejects China’s Trump-Era Tariffs Against Imports From US

 

  • China’s tariffs on $2.4 billion US exports violate WTO rules
  • US or China may appeal the ruling anytime in the next 60 days

China violated its fundamental trade commitments when it imposed tariffs on $2.4 billion worth of US products in retaliation for former President Donald Trump’s steel and aluminum duties, the World Trade Organization said.

In a ruling published Wednesday, a panel of three WTO experts agreed with Washington’s claims that China’s tariffs denied the treatment as a so-called most favored nation, and that Beijing violated other trade concessions it made when it joined the WTO.

https://www.bloomberg.com/news/articles/2023-08-16/wto-rejects-china-s-trump-era-2018-tariffs-against-us-exports