Jeff Aronin’s Har­mo­ny Bio­sciences is ring­ing in a new fi­nanc­ing agree­ment, one that’s bring­ing in hun­dreds of mil­lions of dol­lars.

The Ply­mouth Meet­ing, PA-based biotech has signed a deal with New York in­vest­ment firm Black­stone worth $330 mil­lion, Har­mo­ny an­nounced Tues­day morn­ing as it up­dat­ed in­vestors about its sec­ond quar­ter earn­ings. Funds will come in the form of $300 mil­lion of debt cap­i­tal and $30 mil­lion eq­ui­ty in­vest­ment, the com­pa­ny said.

John Ja­cobs

Har­mo­ny ex­pects to use the new fi­nanc­ing to “ex­pand our port­fo­lio of as­sets in rare, neu­ro­log­i­cal dis­eases while al­so re­duc­ing our an­nu­al in­ter­est ex­pense,” CEO John Ja­cobs said in a state­ment.

Of the $300 mil­lion in debt cap­i­tal, $200 mil­lion will com­prise the prin­ci­pal loan. The oth­er $100 mil­lion will be re­served for a fu­ture loan that can be with­drawn with­in 12 months of the deal clos­ing.

Har­mo­ny’s main rev­enue dri­ver is the drug Wak­ix, which is ap­proved in the US to treat nar­colep­sy in adults with both ex­ces­sive day­time sleepi­ness and cat­a­plexy. But Har­mo­ny has been look­ing to “ex­pand the clin­i­cal util­i­ty” of the drug, ex­ecs said dur­ing Tues­day’s in­vestor pre­sen­ta­tion, and re­cent­ly launched a Phase II study for Wak­ix in my­oton­ic dy­s­tro­phy.

The biotech is al­so con­duct­ing a Phase II tri­al of Prad­er-Willi syn­drome, with da­ta ex­pect­ed in the first half of next year. The my­oton­ic dy­s­tro­phy da­ta are ex­pect­ed by the end of 2022.

In ad­di­tion, Har­mo­ny is run­ning a Phase III study with Bio­pro­jet to study Wak­ix in chil­dren with nar­colep­sy.

Fur­ther down the pipeline, the biotech is try­ing to move an­oth­er can­di­date known as HB-102 in­to a tri­al for nar­colep­sy. Ex­ec­u­tives not­ed there are al­ready some Phase I phar­ma­co­ki­net­ic da­ta avail­able from a study con­duct­ed in the UK.

Har­mo­ny had pre­vi­ous­ly out­lined an ex­pen­sive path to get­ting Wak­ix past the fin­ish line in both nar­colep­sy in­di­ca­tions, not­ing in its S-1 last sum­mer that it shelled out $150 mil­lion for the US li­cense, $50 mil­lion for NDA ac­cep­tance and an­oth­er $77 mil­lion for the first ap­proval. The busi­ness plan proved enough to bring Or­biMed on board in March 2020, how­ev­er, with a $200 mil­lion cred­it fa­cil­i­ty agree­ment.

The biotech is man­aged un­der Aronin’s port­fo­lio at Paragon, and the first US Wak­ix ap­proval came as Aronin had pushed a pric­ing con­tro­ver­sy be­hind him. Back in 2016, Aronin hiked the price of a steroid for Duchenne mus­cu­lar dy­s­tro­phy to $89,000, to the con­ster­na­tion of pa­tients and their fam­i­lies.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”