A roundup of news from the US (Bayer, AstraZeneca, Takeda, Caelum Biosciences, Selecta Biosciences, and MannKind Corporation).

US

Bayer Recalls Select Lots of OTC Antifungal Aerosol Products
Bayer is voluntarily recalling all unexpired Lotrimin AF and Tinactin spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products.

The affected Lotrimin and Tinactin spray products are over-the-counter antifungal products, sold individually or in combo packs. The recalled products are all packaged in aerosol spray cans. The products were distributed in the US, Puerto Rico, Canada, and Mexico through a variety of retail channels. A full list of the impacted products can be found here.

Source: Bayer

---

AstraZeneca’s Alexion Completes Acquisition of Caelum Biosciences
Alexion, part of AstraZeneca following AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals, a Boston-based company focused on rare diseases, has completed its acquisition of Caelum Biosciences, a Bordentown, New Jersey-based bio/pharmaceutical company also focused on rare diseases.

AstraZeneca’s Alexion acquired Caelum for the agreed option exercise price of approximately $150 million. The agreement also provides for additional potential payments to Caelum stockholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones.

Fortress Biotech, a bio/pharmaceutical company and founder of Caelum Biosciences, is eligible to receive approximately 43% of all proceeds, approximately $64 million, from the transaction.

Source: Caelum Biosciences

---

Takeda, Selecta Biosciences in Gene-Therapy Pact
Selecta Biosciences, a Watertown, Massachusetts-based clinical-stage bio/pharmaceutical company, has entered into a strategic licensing agreement with Takeda to develop targeted, gene therapies for two indications within the field of lysosomal storage disorders.

The collaboration will use Selecta’s ImmTOR platform, which is designed to enhance transgene expression and address adeno-associated virus vector immunogenicity constraints.  

Under the agreement, Selecta is entitled to receive an undisclosed upfront payment and up to $1.124 billion in future additional payments over the course of the partnership that are contingent on the achievement of development or commercial milestones or Takeda’s election to continue its activities at specified development stages. Selecta is also eligible for tiered royalties on future commercial sales.

Source: Selecta Biosciences

---

MannKind in Sale-Leaseback Deal for Mfg Facility
MannKind Corporation, a Westlake Village, California company of inhaled therapeutic products, has entered into a sale-leaseback transaction with an affiliate of Creative Manufacturing Properties, for the sale and leaseback of MannKind’s manufacturing space in Danbury, Connecticut.

The real property sale includes 263,900 square feet of manufacturing space in Danbury, Connecticut, but does not include MannKind’s research and development facility. Upon closing of the agreement, MannKind will enter into a 20-year lease agreement with the purchaser, with multiple renewal options available. MannKind will received $102.25 million in gross proceeds upon closing of the sale.

MannKind will continue to operate the Connecticut facility pursuant to the lease. This location is where MannKind produces Afrezza (insulin human) inhalation powder, the company’s inhaled insulin product. It is also where MannKind is preparing to manufacture Tyvaso DPI (inhaled treprostinil) under its collaboration with United Therapeutics, a Silver Spring, Maryland-based bio/pharmaceutical company. Tyvaso DPI is currently being reviewed by the US Food and Drug Administration to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Source: MannKind