Every­one who ever felt the tears well up in their eyes as they bit in­to a red hot chili pep­per should be able to quick­ly gain a ba­sic un­der­stand­ing of what Oys­ter Point Phar­ma is try­ing to do. The team there be­lieves they’re on to a new and bet­ter way to treat dry eye dis­ease. And they now have a whop­ping $93 mil­lion round from some so­phis­ti­cat­ed in­vestors will­ing to back a Phase III to give it a fi­nal push — hope­ful­ly to­ward reg­u­la­tors.

The con­cept is sim­ple: use an in­tranasal ther­a­py to stim­u­late the trigem­i­nal parasym­pa­thet­ic path­way to kick up nat­ur­al tear pro­duc­tion. And they have a re­for­mu­la­tion of Chan­tix — OC-01 — which com­ple­ments an in-house NCE — OC-02 — to pick from for the piv­otal. There’s some mixed but most­ly pos­i­tive mid-stage da­ta on dis­play — some of which reg­u­la­tors ev­i­dent­ly be­lieve are good enough to stand in as a well-con­trolled tri­al need­ed to back up their Phase III.

Sound easy? Any­thing but.

Ste­fan Vi­torovic

While a whole host of biotech star­tups are go­ing af­ter rare dis­eases or can­cer nich­es to keep stud­ies small and com­mer­cial prospects man­age­able, Oys­ter Point staffers — all 8 of them — are go­ing af­ter a com­mon ail­ment suf­fered by tens of mil­lions. In biotech land, it’s ab­solute­ly es­sen­tial that you make a con­vinc­ing case that you can man­age com­mer­cial­iza­tion work on your own; you may even claim that that is your strat­e­gy. 

Part­ners and po­ten­tial buy­ers are put on alert that they don’t have to take any of­fer on the ta­ble. And you have to be able to con­trol your own des­tiny.

Gulp.

Sure, the big com­mer­cial out­fit at Brent Saun­ders’ Al­ler­gan now dom­i­nates the space with Resta­sis — which faces cheap gener­ic com­pe­ti­tion, says Oys­ter Point. But on­ly a frac­tion of pa­tients are be­ing treat­ed prop­er­ly, and Resta­sis and the oth­er prod­ucts are de­liv­ered via eye drops. This new path­way is bet­ter.

That’s Oys­ter Point’s sto­ry, and they’re stick­ing to it as they set out to prove their case.

“Com­pa­nies like us have to plan to take it all the way to the goal line,” Oys­ter Point CEO Jef­frey Nau tells me. Maybe some­body would buy the com­pa­ny, he adds in re­sponse to my ob­vi­ous query, but ei­ther route “is vi­able.”

An IPO could work as well to fund a launch.

Set­ting aside the fea­si­bil­i­ty of a tiny biotech field­ing a con­sumer prod­uct for dry eye dis­ease, Nau’s clear­ly pumped by the $93 mil­lion B round, which does give him a clear shot at tak­ing one of his drugs through a large Phase III study with about 600 or so pa­tients and on to an NDA. The CEO ex­pects to kick that study off at the mid-point of this year, with a read­out in ear­ly 2020.

Nau says his syn­di­cate is back­ing what he be­lieves is the largest sin­gle round ever as­sem­bled for an oph­thal­mol­o­gy up­start. The mon­ey is com­ing from two new lead in­vestors, In­vus Op­por­tu­ni­ties and Fly­ing L Part­ners al­lied with Fal­con Vi­sion. NEA and Ver­sant, which launched the com­pa­ny, are back, joined by Vi­da Ven­tures, where co-founder Ste­fan Vi­torovic has cham­pi­oned their strat­e­gy.

Their mon­ey will al­low the com­pa­ny to quadru­ple its staff in the near-term. And they can even think in terms of the com­mer­cial plan. Which they can han­dle. On their own. If needs be.

Let the Phase III be­gin.

Im­age: Jef­frey Nau. OYS­TER POINT

The US Solicitor General is calling on the Supreme Court to take up a fiercely debated case that could have a chilling effect on generic drug companies’ willingness to bring their copycats to market under so-called “skinny” labels, meaning the generic can only be approved for some of the reference product’s indications.

The case in question relates to GSK’s win over Teva in a long-running battle over the generic giant’s skinny label for GSK’s beta-blocker Coreg (carvedilol). At the time in 2007, Teva’s generic label first included two of the three Coreg indications, but Teva did not initially win approval for the third indication for congestive heart failure.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors Archimed and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Sarissa Capital gained another foothold in its takeover of Amarin with the departure of the Irish drugmaker’s CEO.

Amarin revealed Friday in an SEC filing that Karim Mikhail resigned as president and CEO earlier this week. However, there’s still an ongoing dispute between Mikhail and Amarin, with the now ex-CEO insisting that he has a claim to severance as a result of his resignation. However, Amarin says it disagrees and plans to dispute that claim.

The NIH provided billions of dollars over a decade to foreign companies for research projects that use animals — and the US Government Accountability Office thinks the NIH needs to strengthen its oversight of those sites to ensure the animals’ welfare.

In a report released Thursday based on an investigation requested by Congress, the GAO recommended that the NIH conduct site visits and require third-party verification of the annual reports submitted by the companies in order to “provide reasonable assurance that award recipients’ annual self-reported project information is reliable and adequate to ensure the humane care and use of laboratory animals.”