Repatha = niche drug, but Medicines Company PCSK9 is mass market PCP

Amgen is done!!! siRNA is literally pennies to manufacture, even cheaper than small molecules. That plus twice yearly dosing means this thing can be priced at $1200 a year. This product will be priced so that it can have the PCP access without restrictions and even medicare patients can afford it with the low list price.

Amgen Repatha COGS will never allow it to be priced as low as what this product can do. They will destroy Repatha by making it a mass market product knowing that Amgen could never do that based on COGS of being a biologic.

Get ready for Repatha sales to drop once this drug hits as it will benefit from the class effect of repatha and praluent.

The largest costs in commercial will be trials and sales force. MedCo will sell to a big pharma and add it to the bag. Novartis will Entreso makes a lot of sense! Vas is very aggressive.


Whatever worries lingered around The Medicines Company’s longer-lasting PCSK9 cholesterol fighter should clear up now, thanks to a set of pivotal phase 3 data that shows the drug is at least as safe and effective as its two marketed rivals.

In a 1,617-patient study, inclisiran cut bad cholesterol by 54% when added to statin therapy, a number comparable to the 50%-plus stats put up by existing PCSK9 inhibitors—Amgen's Repatha and Sanofi and Regeneron's Praluent—in their own pivotal trials.

Industry watchers have been more focused on the med's safety profile, though, because it uses an Alnlym Pharmaceuticals delivery platform recently linked with liver toxicity concerns. Now, investors in both firms are likely reassured by the new phase 3 trial, dubbed Orion-11.

Inclisiran has shown a clean safety profile in earlier phases of clinical trials, “but now we can confirm that, because of the size of the study, it’s very safe and there’s no concerns of liver function or renal function,” CEO Mark Timney said.

Between the placebo and inclisiran arms, liver enzyme changes were similar at 0.5% versus 0.5% for ALT and 0.5% versus 0.2% for AST. As for kidney function, plasma creatinine increases were 3.9% and 2.5%, respectively, The Medicines Company reported. Overall, patients who experienced serious adverse events during treatment were around 22% in both groups, and there was no important difference in categories, either, the company’s chief development officer Peter Wijingaard told FiercePharma.

Ability to lower LDL cholesterol is of course important because high levels have long been linked with high risk of cardiovascular disease. But improving cardiovascular outcomes is arguably more important, especially because Praluent and Repatha have each posted heart-helping results.

Inclisiran has some early data to back its case. In the current trial, investigators noticed a statistically significant difference between placebo and inclisiran in the rates of heart attack (2.7% versus 1.2%) and strokes (1.0% versus 0.2%).

The study wasn’t designed to show CV benefits, Wijingaard acknowledged. But the stats are a good sign for the Orion-4 outcomes trial, which is on track to read out around 2024, and fall in line with what the company's expecting from inclisiran given historic trial evidence in the PCSK9 field.

Even without the outcomes data, though, MedCo believes it’s in good shape. The company's market research has shown “that [physicians and patients] will not wait until we have outcomes data,” Timney said. “The LDL-c lowering is heavily validated marker of outcomes improvement, and we hear phrases like ‘We did not wait for outcomes with Crestor, why would we wait here?’”

A more relevant comparison these days, given payer limitations, would be Repatha and Praluent, which still face some authorization hurdles even after major price cuts. But MedCo thinks inclisiran's twice-yearly dosing—compared with every two weeks or once a month for the existing PCSK9s—can give it a marketing edge.

And it's not just convenience in its favor, either, Timney said. The new med is injected by a healthcare provider, which should help with compliance, too.

It “aligns with when these types of patients visit their physician, and therefore is starting to get these additive benefits such as the ability to control adherence,” Timney said. According to him, up to two-thirds of patients don’t adhere to proven first-line cholesterol treatments after one year.

Inclisiran also works differently from Repatha and Praluent, which are antibodies that directly attack the PCSK9 protein. Inclisiran targets the RNA that eventually makes that protein. MedCo has long touted inclisiran as a potential first-in-class small-interfering RNA (siRNA) drug.

Orion-11 tested inclisiran in patients outside the U.S. with atherosclerotic cardiovascular disease, and it's the first phase 3 to read out. Orion-9 in familial hypercholesterolemia and Orion-10, which focuses on U.S. patients, are expected to report data later this year. Combined, the three studies will form inclisiran’s new drug application package to the FDA by year-end and in Europe early 2020, the company says.

To prepare for a launch, MedCo has started pre-commercialization work that’s “with the same level of robustness that a large pharmaceutical company would exercise,” said Timney, whose resume includes a stint at Merck & Co. as U.S. pharma chief and at Purdue Pharma as CEO.

MedCo already has a small team of medical science liaisons and has account executives in place on the payer side, Timney said.

As Amgen, Regeneron and Sanofi have learned, pricing and payer support could be a major problem to success—after all, that’s why they lowered Repatha’s and Praluent’s prices by 60% recently. Timney wouldn’t give away details on his pricing strategy, but said the MedCo drug will be “positioned very differently” on the market because it “offers a vastly different value proposition compared to any other lipid-lowering therapy.”

 

If this drug is priced low, it will do what Prolia should have done if it came to market at a good price.

 

rumors that Sanofi will divest praluent and acquire this product. This gets rid of SEC monopoly clause and they have the field force ready to execute. Medicine Co BD has been blowing up since this new data.

 

Statins for most patient are still very effective and very cheap.

 

What now folks? What will happen ? 1. Amgen buys another cardio drug? 2. Downsize sales force? 3. Drop price again?

 

Emergency elevation of Jay_Chiang to CEO to save the day. jay summons MIT magic and calls for China to help.

 

I can confirm that Medicine Company BD is very busy with data rooms and are running a process. Repatha peak shares now in significant jeopardy. It’s embarrassing how much Amgen pays external consultants to run “war gaming” scenarios. This new development puts a lot more pressure on Otezla to reach peak sales faster. That pressure to execute will be the death of Otezla when sales growth stalls as the company is left with a subpar commercial team. To say Amgen is poorly run is misnomer considering how inept management is.

Amgen BD still needs another acquisition.

 

True.... what's your point?? If statins work then that's not the Repatha patient anyway.

 

Sales are showing that the market based on the current data has become much more limited since the products first came out. Sales don't lie. This will be the case for the new drug coming out also.

 

Medicine Co will price this like a branded Primary care drug and make $$ from volume. Amgen can’t do that due to COGS from biologics manufacturing is $$.

They will get used first based on the access due to price for both commercial and Medicare.

 

This is all nonsense. If this drug gets approved it will be accessed thru the medical benefit. Not many PCPs or cardiologists are familiar with or amenable to buying and billing injectables. The Medicine Company will have a difficult time getting this drug off the ground in this market using the medical benefit. Pass the popcorn this will be interesting to watch.

 

Specialty pharmacy doofus. Will be like promise but pricing will Determine access. Low price means good access

 

Too many people selling repatha it’s a niche drug not going to grow especially with medicines drug coming as well as another

 

Yes won’t grow market flat take your lose ...repatha territories need to be downsized , overkill of details , can’t and won’t change metrics don’t matter , reps fudge it all upper management get a grip

 

Yep.... reps BS calls to satisfy metrics and then that leaves managers wide open to use that against them and get them fired even though they tell you to "do what you have to do" to reach that call number. At least that's how it works in our area. Our manager has had people fired for "faking calls" but protects the reps she likes and allows them to bs every day. Too many people selling a niche drug.

 

Repatha is the greatest drug ever! Why don’t you see it?

 

In your mind it is but it sure doesn't sell like it.