ENDO INTERNATIONAL TO ACQUIRE BIOSPECIFICS TECHNOLOGIES FOR $540M

Endo International has agreed to acquire BioSpecifics Technologies in a cash-based transaction valued at approximately $540m.

According to the agreement, Endo, via a wholly-owned subsidiary, will initiate an all-cash tender offer to acquire all the outstanding common stock of BioSpecifics for $88.50 per share.

Endo and BioSpecifics have been strategic partners since 2004.

Under the deal, BioSpecifics will receive a royalty stream from Endo related to the latter’s collagenase-based therapies.

The therapies include Xiaflex, marketed by Endo for the treatment of Dupuytren’s contracture and Peyronie’s disease, and Qwo, an FDA-approved injectable treatment for cellulite.

Qwo is expected to be launched by Endo Aesthetics next year.

The Edwin H Wegman Marital Trust signed a Support Agreement committing it to tender its shares into the tender offer. The closing of the tender offer will be subject to certain conditions.

MODERNA INITIATES ROLLING SUBMISSION FOR COVID-19 VACCINE

Moderna has initiated a rolling submission to Health Canada for its vaccine candidate against Covid-19, mRNA-1273.

The decision is backed by data from a preclinical viral challenge study of mRNA-1273 and positive interim analysis of Phase I trial of the vaccine in adults.

Moderna’s rolling submission was accepted under the Candian Minister of Health’s Interim Order, which allows firms to submit trial data on safety and efficacy as they become available.

According to the Phase I interim analysis data, mRNA-1273 was generally well-tolerated and prompted fast and robust immune responses against SARS-CoV-2.

The vaccine candidate is presently in a randomised, placebo-controlled Phase III COVE trial of 30,000 adults at a dose level of 100µg in the US.

As of 9 October, the trial enrolled about 28,618 adults with 22,194 of them having received their second vaccination.

ASTRAZENECA SECURES $486M FROM US FOR COVID-19 ANTIBODY

AstraZeneca has signed a $486m deal with the US Biomedical Advanced Research and Development Authority to supply 100,000 doses of its long-acting antibody (LAAB) cocktail, AZD7442, for Covid-19 treatment.

AZD7442 combines two LAABs obtained from convalescent patients after Covid-19 infection. The LAABs could potentially minimise the risk of resistance developed by SARS-CoV-2.

Engineered with half-life extension and decreased Fc receptor binding, the LAABs have the potential to provide six to 12 months of protection against the disease with a single administration.

In the coming weeks, AZD7442 will progress into two Phase III trials in a total of over 6,000 subjects enrolled at sites across the US and other countries.

EC SIGNS AGREEMENT FOR ADDITIONAL DOSES OF GILEAD’S COVID-19 DRUG

The European Commission has signed a joint procurement agreement with Gilead Sciences for the supply of up to 500,000 treatment courses of the company’s Covid-19 drug, Veklury (remdesivir).

The agreement involves 36 participants, including all countries in the European Union (EU), the European Economic Area and the UK, along with six candidate countries and potential candidates.

All participating countries will be able to buy Velkury directly from Gilead for real-time demand and stockpiling. The agreement covers the coming six months, with an option for extension.

Velkury is currently the only drug in the EU to hold conditional marketing authorisation for Covid-19 patients who require oxygen supply.

PFIZER COMPLETES $200M INVESTMENT IN CSTONE

CStone Pharmaceuticals has completed the previously announced share subscription agreement through which a Pfizer affiliate subscribed for newly issued CStone shares at around $200m.

In September, CStone entered a multifaceted strategic partnership with Pfizer to develop and commercialise late-stage oncology therapies in China.

Hong Kong’s Listing Committee of the Stock Exchange approved the listing of 115,928,803 additional shares subscribed by Pfizer at around HK$13.37 ($1.725) per share.

Pfizer now owns almost 9.9% of stake in CStone. As part of the agreement, Pfizer will get an exclusive licence to commercialise the drug candidate in mainland China.

The deal will extend financing to develop and commercialise CStone’s sugemalimab, an investigational anti-PD-L1 monoclonal antibody for high-incidence cancers, including lung, gastric and oesophageal cancers, among others.

MALLINCKRODT FILES FOR BANKRUPTCY TO RESOLVE OPIOID CLAIMS

Mallinckrodt has initiated Chapter 11 proceedings in the US Bankruptcy Court for the District of Delaware to modify its capital structure, reduce debt and settle opioid claims.

The company and substantially all of its subsidiaries in the US filed the petitions.

In February, Mallinckrodt entered into a tentative agreement with 47 states, territories and lawyers in the US to pay $1.6bn to settle thousands of opioid-related lawsuits.

Furthermore, Mallinckrodt lost a legal battle and had to pay higher rebates to state Medicaid programmes for its multiple-sclerosis medication, Acthar Gel.

Mallinckrodt plans to utilise the Chapter 11 process for a restructuring support agreement to resolve opioid claims and financial restructuring to lower its total debt by around $1.3bn.

The company will also settle Acthar Gel-related issues, which include CMS Medicaid rebate dispute, associated False Claims Act (FCA) lawsuit and another FCA lawsuit on the interactions of Acthar’s previous owners with a charitable foundation.