Search This Blog

Monday, May 6, 2019

Ligand Acquires Milestone and Royalty Rights to SB206 from Novan

Ligand Pharmaceuticals Inc. (NASDAQ: LGND) announces the acquisition of economic rights to SB206 from Novan, Inc. SB206 is a Phase 3 topical antiviral gel for the treatment of skin infections, including molluscum contagiosum. Ligand will pay $12 million to Novan and in return will be entitled to receive a tiered royalty of 7% to 10%, as well as up to $20 million in regulatory and commercial milestones. Novan is responsible for all expenses to develop or commercialize SB206, and will use 100% of the proceeds from this transaction in the development and pursuit of regulatory approval for SB206.
“This deal enables Ligand to participate in the potential future revenue of a promising Phase 3 stage asset with a potential commercial launch in 2021. The drug candidate targets a condition mostly affecting children and with a significant unmet medical need,” said John Higgins, Chief Executive Officer of Ligand. “We believe Novan is a well-capitalized company with an experienced management team. This deal adds an attractive late-stage asset to our growing list of partnered programs that could be approved and launch within the next three years.”

Novan is developing SB206 as a nitric-oxide-based topical gel for the treatment of viral skin infections, with a current focus on the treatment of molluscum contagiosum, a contagious skin infection caused by the molluscipoxvirus. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) for the treatment of molluscum. Nitric oxide has diverse biological activity within the body, affecting the immune, cardio/pulmonary and neurological systems, and depending on dose and release kinetics, nitric oxide can have agonistic or antagonistic effects. The role and mechanics of nitric oxide have been well researched. Novan’s technology platform is the first macromolecular platform to achieve stable, tunable and druggable delivery of nitric oxide. SB206, if approved, could be a topical, at-home, caregiver-applied therapy with a rapid treatment benefit. Novan’s issued U.S. and foreign patents and pending U.S. and foreign patent applications, if issued, relating to SB206 are projected to expire between 2026 and 2034.

Intermolecular (IMI) to be acquired by Merck KGaA for $1.20/share

Intermolecular, Inc. (NASDAQ: IMI) has signed a definitive agreement pursuant to which a wholly owned subsidiary of Merck KGaA, Darmstadt, Germany, a leading science and technology company, will acquire Intermolecular for $1.20 per share in an all cash transaction, representing an equity value of Intermolecular of approximately $62 million. The acquisition has been unanimously approved by Intermolecular’s Board of Directors and the Executive Board of Merck KGaA, Darmstadt, Germany.
“We are pleased to become an integral part of Merck KGaA, Darmstadt, Germany’s leading electronic materials business and look forward to all of the new and exciting opportunities we see for our customers and employees. We believe our technology expertise is very complementary and creates a unique offering that will continue to shape the innovations of tomorrow,” said Chris Kramer, President and Chief Executive Officer of Intermolecular.
“Intermolecular’s unique capabilities in rapid material screening, in combination with the R&D pipeline of Merck KGaA, Darmstadt, Germany, will allow us to offer our customers faster materials innovation, through parallel composition experiment and full performance testing and characterization,” said Kai Beckmann, member of the Merck KGaA, Darmstadt, Germany, Executive Board and CEO of Performance Materials. “We are excited to join forces with Intermolecular and bring significant advantages to our customers compared to conventional materials R&D.”
The transaction is expected to close in the second half of 2019, subject to the approval of Intermolecular’s stockholders, clearance by the Committee on Foreign Investment in the United States (CFIUS) and the satisfaction of other customary closing conditions.
Merck KGaA, Darmstadt, Germany, will acquire Intermolecular through its wholly owned subsidiary EMD Group Holding II, Inc.
As a result of this transaction, Intermolecular will not be holding its previously scheduled conference call on May 14, 2019.
Cowen served as exclusive financial advisor to Intermolecular and Latham & Watkins LLP served as Intermolecular’s legal advisor. Nixon Peabody LLP served as Merck KGaA, Darmstadt, Germany’s legal advisor.

Savara receives fast track designation from FDA for Molgradex

Savara announced that the U.S. Food and Drug Administration granted Fast Track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor. Molgradex, the Company’s lead product candidate, is being investigated in a pivotal Phase 3 study, called IMPALA, for the treatment of autoimmune pulmonary alveolar proteinosis. Topline results from the study are expected in June 2019. Positive results would facilitate the submission of a Biologics License Application in the first half of 2020, with an anticipated commercial launch later in 2020 or early 2021.
https://thefly.com/landingPageNews.php?id=2903653

vTv Therapeutics upped to Outperform from Market Perform at Northland

https://thefly.com/landingPageNews.php?id=2903663

Bausch Health raises FY19 revenue view to $8.35B-$8.55B from $8.30-$8.50B

FY19 consensus $8.47B

Mallinckrodt announces prelim results from Phase 4 registry for INOmax gas

Mallinckrodt announced preliminary results of a planned interim analysis from the company’s Phase 4 registry assessing the use of INOmax gas, for inhalation, for premature neonates versus term and near-term neonates with pulmonary hypertension, or PH. The primary outcome measure compares the incidence of mechanically ventilated subjects with PH who achieve at least a 25% improvement in Oxygenation Index, or OI, from baseline, or Surrogate Oxygenation Index, or SOI, for subjects who are not ventilated, between gestation age groups. OI is commonly used to evaluate the severity of hypoxic respiratory failur, or HRF, in neonates with PH. The planned interim analysis occurred at the approximate midway point of enrollment. The preliminary analysis found that, at this juncture in the study, approximately 86% of both cohorts showed a 25% or greater improvement in OI or SOI during the treatment period. The safety and efficacy of INOmax nitric oxide gas for treating HRF in premature neonates with PH has not been evaluated by the FDA.

Aclaris Therapeutics initiated at SVB Leerink

Aclaris Therapeutics initiated with an Outperform at SVB Leerink. SVB Leerink analyst Pasha Sarraf initiated Aclaris Therapeutics with an Outperform rating and $13 price target.