Products

Date: 2015-04-20

Type of information: Granting of a Market Authorisation in the US

Product name: new formulation of Minocin®

Compound: minocycline

Therapeutic area: Infectious diseases

Action mechanism: antibiotic/ protein-synthesis inhibitor/ tetracycline derivative

• In January  2018, The Medicines Company announced the closing of the sale of its infectious disease business unit to Melinta Therapeutics for consideration consisting of $215 million of guaranteed cash, approximately 3.3 million shares of Melinta common stock, tiered royalty payments of 5% to 25% on worldwide net sales of Vabomere™, Orbactiv®  and 
• Minocin® IV, and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.

Company: The Medicines Company (USA - NJ)

Disease: infections due to susceptible strains of important designated gram-positive and gram-negative pathogens, including infections due to Acinetobacter species

Latest news:

• • On April 20, 2015, The Medicines Company announced that the FDA has approved a supplemental new drug application (sNDA) for a new formulation of Minocin® (minocycline) for Injection. The FDA has also granted Qualified Infectious Disease Product (QIDP) designation for the new formulation of Minocin® for Injection under the Generating Antibiotic Incentives Now Act (GAIN Act). The designation, the third granted to a product in the Company’s infectious disease portfolio, would qualify Minocin® for Injection for priority review and five years of marketing exclusivity upon an approval of the additional potential indications. The approved indications for Minocin® for Injection includes the treatment of infections due to susceptible strains of several important designated gram-positive and gram-negative pathogens, including infections due to Acinetobacter species, which typically occur in hospitalized patients.
• The FDA granted QIDP designation for the following potential indications involving gram-negative pathogens:
• Treatment of hospital acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
• Treatment of persistent pulmonary infections in patients with cystic fibrosis caused by Burkholderia cepacia complex or Stenotrophomonas maltophilia.
• Treatment of pulmonary exacerbations in patients with cystic fibrosis caused by Burkholderia cepacia complex or Stenotrophomonas maltophilia.
• Treatment of pulmonary infections including pneumonia or lung abscess in patients with chronic granulomatous disease caused by Burkholderia cepacia complex.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2015-04-20

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes