ANI Files Another Controlled Substances Application ...
Looks like it's going to be an interesting day!
There are Currently ...
133 psilocybin trials listed at Clinicaltrials.gov worldwide:
With quite a few here in the US. The application ANI submitted states the following:
Psilocybin (7437) will be imported to support research, formulation development, and clinical trials of an experimental drug product for the United States market.
Saw That Last Week ...
Here is the FDA news release:
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Agency Recommendations Aim to Inform Psychedelic Drug Development
For Immediate Release:
June 23, 2023
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.
There has been growing interest in the therapeutic potential of psychedelic drugs in recent years. They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions. However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges that require careful consideration.
“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”
The purpose of the draft guidance is to advise researchers on study design and other considerations as they develop medications that contain psychedelics. Within the draft guidance, the term psychedelics refers to “classic psychedelics,” typically understood to be drugs such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system, as well as “entactogens” or “empathogens” such as methylenedioxymethamphetamine (MDMA).
The document describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements. For example, psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. As a result, there is the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development. For psychedelics that are currently Schedule I controlled substances, the draft guidance notes that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration regulatory requirements.
The evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs. However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled. The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect.
The FDA is encouraging the public to provide comments on the draft guidance. Comments should be submitted within 60 days to ensure the agency considers them.
It looks like ANI has resubmitted their applications back in late March and early April:
From Veeva Blog ...
How ANI Pharmaceuticals Launched New Rare Disease Product in Under 90 Days
Jun 27, 2023 | Doug Caldwell
Reaching and engaging healthcare professionals (HCPs) who serve niche patient populations — such as specific autoimmune and inflammatory conditions — can be challenging. Yet, despite these complexities, ANI Pharmaceuticals delivered its FDA-approved Purified Cortrophin® Gel in less than three months with limited resources.
The need for product launch speed in rare diseases
After completing its supplemental new drug application (sNDA) filing, ANI received a PDUFA date more quickly than the team anticipated. It had to accelerate its commercialization efforts and drive precision engagement.
“We stood up a full commercial launch in about 75 days,” said Bob Acropolis, senior director of operations and analytics at ANI. “Having an integrated suite of commercial solutions helped streamline the entire process.”
Integrated analytics and unified data insights in hours
Mike Rifflard, VP of operations at ANI, helped deliver this major launch on a tight timeline with a talented but lean team. One of the first steps was to help his team understand the patient journey with Veeva Compass.
Rifflard also credits Veeva Commercial Cloud for helping them launch quickly and optimize sales territory KPIs.
“Veeva’s integrated solutions allowed us to execute faster and access insights quicker than if we had used a more traditional, separate application approach,” Rifflard said. Having integrated solutions meant that Rifflard and his team avoided the burdensome process of pulling insights from disparate systems.
Integrated analytics with Veeva Nitro also meant that Rifflard could quickly change the plan as things evolved. Field engagement metrics fed directly to leadership dashboards made it easy to keep a pulse on progress. As a result, ANI maintained high levels of engagement with target HCPs and achieved a 30% click-through rate on all HCP email communications.
Six months after launch, the team revisited KPIs, and their hypotheses about the market issues with territory alignment became evident. However, insights from Veeva Nitro integrated with Veeva Align for territory planning provided re-aligned territories and maps in just two weeks.
Minimizing complexity and adding value
Having an industry-specific Veeva CRM and master data management (MDM) platform ready from Day One meant ANI could focus on preparing its sales team for launch. “In the past, when I’ve used a third-party or different MDM platform to set up a CRM, the integration became very complex. Getting everything to work together was a tremendous effort, and it often didn’t go right the first time,” shared Rifflard.
Hybrid field teams need their CRM to provide a collaborative platform for monitoring engagements across the organization. Veeva CRM provides the ANI field team with a single view of each HCP, including engagement with medical and sales reps and participation in scientific congresses and social media. Field teams also can access information about which doctors visit high-risk patients and what those HCPs tend to prescribe.
“Having this information accessible within the CRM system facilitates more thoughtful and helpful conversations with providers and has helped facilitate the sales teams’ success and high click-through email rates,” Acropolis said.
Sustaining post-launch success
Reflecting on a speedy but successful launch, the team looks forward to taking more time to pull insights from the rich data they can access and optimize the patient journey.
“Getting a whole commercial business solution up and running in two and a half months seems impossible, but it’s amazing what you can do if you get the right people and partners in place”.
Mike Rifflard, Vice President Operations, ANI Pharmaceuticals
Doesn't Look Good for the CVR's ...
Wanted to post this several weeks ago before the First Quarter results, but waited to see if there were any changes. This from the Fourth Quarter and Full Year Financial results back in March:
Contingent Value Rights
Our contingent value rights (“CVRs”), which were granted coincident with our merger with BioSante Pharmaceuticals, Inc. and expire in June 2023, are considered to be contingent consideration and are classified as liabilities. As such, the CVRs were recorded as purchase consideration at their estimated fair value, using Level 3 inputs, and are marked to market each reporting period until settlement. The fair value of CVRs is estimated using the present value of management’s projection of the expected payments pursuant to the terms of the CVR agreement, which is the primary unobservable input. If our projection or expected payments were to increase substantially, the value of the CVRs could increase as a result. The present value of the liability was calculated using a discount rate of 15%. We determined that the fair value of the CVRs was immaterial as of December 31, 2022 and 2021. We also determined that the changes in such fair value were immaterial for the years ended December 31, 2022, 2021, and 2020.
Unfortunately, for many of us holding them all these years, it ain't looking good!
Flurry of Upgrades This Morning ...
ANI Pharmaceuticals (ANIP) PT Raised to $49 at Raymond James
ANI Pharmaceuticals (ANIP) PT Raised to $52 at Truist Securities
ANI Pharmaceuticals price target raised to $60 from $53 at H.C. Wainwright
There's a presentation today at noon:
From Reuters ...
Here's a direct quote:
"We have seen an increase in demand since the ruling earlier this month," a spokesperson for Baudette, Minnesota-based ANI Pharmaceuticals (ANIP.O), one of the companies that makes misoprostol, told Reuters. "We have ramped up our manufacturing and are currently prepared to meet the increased demand we are seeing."
Interestingly, ANI launched their version of Misoprostol Tablets, 100 mcg and 200 mcg exactly one year ago today. It is the generic version of the Reference Listed Drug (RLD) Cytotec®. Mr. Lalwani is quoted in the press release:
"We are pleased to announce the launch of AB rated Misoprostol Tablets. The AB rating indicates that our product meets necessary bioequivalence requirements, thus is therapeutically equivalent to the RLD. This rating provides us with an advantage versus other available generics. In light of the recent drug shortage, the commercialization of Misoprostol Tablets highlights our commitment to rapidly bringing limited market competition generic products to our patients in need and to our customers."
From The San Francisco Chronicle ...
The state has already bought and received 250,000 misoprostol pills from ANI Pharmaceuticals, according to the governor’s office, and has negotiated an agreement to buy up to 2 million pills from the drugmaker through its own prescription drug label CalRx.
Guggnheim Initiates Coverage ...
Guggenheim starts ANI Pharmaceuticals at Buy on cortrophin gel's potential 06:33 ANIP As previously reported, Guggenheim analyst Vamil Divan initiated coverage of ANI Pharmaceuticals with a Buy rating and $55 price target, citing a "bullish view" that is driven primarily by enthusiasm on purified cortrophin gel's potential. The firm, which thinks cortrophin can reach annual sales of about $220M by 2028, also believes the Novitium acquisition will help drive potential upside in the generics business.
Informative Article on Delivering to Rare Disease Patients ...
Below is an excerpt from the article pertaining to ANI Pharmaceuticals ability to deliver to this market:
Data can pinpoint the path forward, even when patient journeys are complex and varied (like in rare autoimmune diseases). In North America, end-to-end patient data is increasingly used to map the most likely patient pathways from diagnosis to treatment. For example, ANI Pharmaceuticals used advanced customer segmentation and technology to build specialised field teams in months, empowering them with information on different patient segments, therapeutic areas, and HCP customers. Field teams succeed because they prioritise engagement based on which doctors have the most appropriate patient visits and what they tend to prescribe.
It will be interesting to see if it's reflexed positively in the Cortrophin sales numbers to be released in the 4th Quarter and Full Year 2022 Financial Results.
From Creakyjoints.org ...
What Is Corticotrophin (ACTH)?
PUBLISHED 12/15/22 BY BARBARA BRODY
This steroid alternative may be a useful treatment for some patients with gout, rheumatoid arthritis, and other autoimmune disorders.
Corticotrophin, also called adrenocorticotropic hormone (ACTH), is an FDA-approved treatment for numerous conditions, including ankylosing spondylitis (AS), gout, psoriatic arthritis (PsA), and rheumatoid arthritis (RA). What’s more, it’s been on the market since the 1950s. So why haven’t you heard of it?
The answer is complicated, but it largely boils down to cost and access. ACTH is more expensive than a simple steroid treatment, and it’s obtained from a specialty pharmacy — a trustworthy resource that can help patients navigate health insurance, side effects, dosing and administration, and home delivery of the drug.
ACTH is used in lieu of corticosteroids (like prednisone or prednisolone) to control rheumatic and autoimmune disease flares; and like corticosteroids, it doesn’t slow the progression of the disease. This is the job of the biologic or biosimilar.
ACTH is typically reserved to treat severe disease that isn’t responding to numerous other therapies, or for patients who are intolerant to steroids. One key benefit: It’s effective at a much lower dose than steroids, reducing the risk of possible side effects.
What Is ACTH (corticotrophin)?
ACTH is a hormone that’s naturally produced by the pituitary gland. It travels to the adrenal glands where it prompts the secretion of cortisol, a stress hormone.
ACTH is sold under two brand names; no generic version is available. One is Acthar Gel, which is made by Mallinckrodt Pharmaceuticals and has been on the market since the 1950s. The other is Cortrophin Gel which was first approved by the FDA in 1954 but stopped being produced in the 1980s. Cortrophin was reintroduced to the market in 2021, about five years after ANI Pharmaceuticals acquired it from the previous manufacturer (Merck).
ANI Pharmaceutical’s list price for Cortrophin Gel is about half that of Mallincrtodt’s — $3,500 vs. $7,000 — yet most patients don’t pay the list price for a drug. Instead, the patient pays a fraction of the cost of the drug through their employer-provided insurance, Medicare, Medicaid, or Tricare/Veteran’s Administration. This can include copays, copay cards, deductibles, and the insurance premium itself. The fact that Cortrophin Gel has a 50 percent lower list price may induce some insurers to add it to the list of drugs they offer.
How taking ACTH helps people with autoimmune conditions isn’t fully understood, but it is believed to stimulate the body to secrete more steroids, including cortisol. It also binds to melanocortin receptors, says Frederick T. Murphy, DO, a board-certified rheumatologist who is affiliated with several Pennsylvania-area hospitals. (These receptors are part of an ancient modeling system that is involved in dampening inflammation.) ACTH also decreases levels of interleukin-1 (IL-1), an inflammatory protein that plays a major role in gout, Dr. Murphy adds.
How Well Does It Work?
As with corticosteroids like prednisone, ACTH isn’t designed to be a routine treatment for a chronic condition. But when used to combat rheumatic disease flares, especially gout, “it’s a very effective therapy,” says Dr. Murphy. The problem: “A lot of drug formularies won’t approve it.” (A formulary is a list of drugs insurers prefer because they are more profitable.)
Research suggests that ACTH typically works just as well as steroids like prednisone, at least for certain conditions. A 2019 research review of this drug’s use in gout found that it was “fast-acting, typically relieving the painful symptoms of acute gout within 24 [hours] of treatment. Furthermore, the average number of days needed to achieve 100 percent resolution of gout symptoms in patients treated with [ACTH] was similar to those of the corticosteroid triamcinolone.”
Corticosteroids and ACTH have the potential to cause the same side effects, including stomach upset, mood swings, high blood sugar, high cholesterol, and osteoporosis. The risk of severe side effects increases along with the dose, which is why doctors aim to keep patients on the lowest effective dose for the shortest period of time necessary.
Anecdotally speaking, however, Dr. Murphy says that ACTH tends to cause fewer side effects, mostly because patients who are having a flare (perhaps related to lupus or gout), can usually get off the drug very quickly.
Additionally, he adds that patients who are flaring and given prednisone often require 20 mg to 40 mg of prednisone (or the equivalent) per day — and the risk of serious side effects goes up when you exceed 10mg.
With ACTH, flares can often be successfully treated with a dose that raises cortisol levels in the body in a way that’s equivalent to taking 10 mg or less per day of prednisone.
Who Might Benefit from It?
ACTH may be used treat a variety of conditions, including AS, gout, lupus, multiple sclerosis, PsA, and RA.
As with steroids, it’s not usually a routine medication but rather one that might be used to dampen a flare. ACTH is not a disease-modifying drug, which means it won’t actually slow the progression of a disease such as RA.
Roy Fleischmann, MD, Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, who has been involved in several studies regarding the use of ACTH in RA, told us he wouldn’t necessarily use this drug for inflammatory arthritis flares. However, it might be appropriate for inflammatory arthritis patients whose disease activity remains high despite taking multiple medications, including prednisone, he said.
Dr. Murphy sometimes uses ACTH in patients who have lupus, sarcoidosis, or gout — “in people who have refractory, tophaceous gout,” notes Dr. Murphy. Refractory gout means that it hasn’t been controlled by other medications, including colchicine and pegloticase (Krystexxa). Tophaceous gout is the most severe form of the disease; it’s characterized by the presence of numerous urate crystals (tophi) that look like bumps or nodules under the skin. “I’d love to use it for gout flare ups as well,” not just the most severe, refractory cases, he adds. “But prednisone is so much less expensive.”
How Much Does ACTH Cost?
Pricing varies, but Dr. Murphy estimates that Acthar costs about $7,000 per treatment and that Cortrophin costs about half ($3,500). The corticosteroid prednisone, in contract, costs around $10 for 7 tablets, according to drugs.com. But, as noted above, patients do not ordinarily pay the list price for a drug. It can cost very little or, in some case, nothing, depending on insurance coverage
Despite the low cost, not everyone who’s flaring responds to corticosteroids. “Patients who are refractory or intolerant to corticosteroids have an especially urgent need for effective alternatives and are at risk of going organ damage with long-term disease,” Mary Pao Seideman, MD, PhD, Chief Medical Officer of ANI Pharmaceuticals, said in a release.
Both Mallinckrodt (makers of Acthar) and ANI (makers of Cortrophin) offer patient assistance programs to make corticotrophin more accessible to patients. Some patients may even be able to access one of these drugs at low or no cost, despite the high sticker price.
The bottom line: The more you know about the available treatments, the more equipped you’ll be to participate in shared decision making with your provider. Talk to your doctor about choosing the best medication for you — including what will work best with your medical history, symptoms, treatment goals, overall health, and budget.
From Real Money ...
This Biopharma 'Fits the Bill' as a Growth Play
These kind of names are in short supply in the current market.
With the economy looking like it is heading towards recession in 2023, reliable growth names with reasonable valuations are in short supply in the current market.
One name that fits that bill is a biopharma company I have not discussed in a while. The company sports a forward earnings ratio in the low teens with profits expected to jump noticeably in the coming year.
Let's revisit it as a covered call trade opportunity.
ANI Pharmaceuticals (ANIP) is a roughly $650 million market cap specialty pharmaceutical company focused on the development and marketing of generic and branded drugs with niche or high barrier to entry characteristics. The Minnesota-based company's product portfolio consists of approximately 85 generic products and 15 branded drugs.
ANI's revenues should be up just over 40% in 2022 to at least $300 million. The recent launch of Cortrophin Gel has been a key growth driver for the company this year and should deliver $40 million to $45 million in sales in 2022, which is up about $5 million from previous guidance. Cortrophin Gel sales rose to $12.6 million in the third quarter, up more than 20% sequentially from the $10.2 million in the second quarter. This product is rapidly gaining market share in an approximately $600 million annual market.
Management is in the process of consolidating some of its manufacturing facilities, which should deliver $7 million to $8 million worth of annual cost savings when completed. This is one reason earnings per share are projected to jump markedly in 2023 even as sales growth is expected to level out in the mid-teens next year. Analyst estimates for earnings are in a range of roughly $2.50 to $3.25 a share for 2023. For comparison, ANI is tracking towards just over $1.35 in EPS this year.
The company is growing by launching new products and by acquiring niche products on the cheap. ANI has averaged 2-4 small deals on an annual basis over the past decade. EBITDA has jumped from $4.3 million in Q1 to $9.9 million in Q2 to $19.6 million in the third quarter of 2022. The company's balance sheet is also in good shape, with no major debt maturities until 2027.
Option Strategy for ANI
This is how one can execute a covered call position in ANIP. Remember, covered call orders involve buying an equity and simultaneously selling just out of the money call strikes against the new position.
Using the July $40 call strikes, fashion a covered call order with a net debit in the $33.00 to $33.50 range (net stock price - option premium). This strategy provides downside protection of 16% and potential upside of 20% over the eight-month option duration even if the stock does nothing from current trading levels.
Don't know if institutional investors are more comfortable with the spending roll out of Cortrophin or not, but I do know that institutions control almost 75% of the outstanding stock so the implied satisfaction is very possible. Also, the forward guidance that the Company provided back in August during the second quarter financial results, especially the Cortrophin net revenue increase from $35 -$40 million to $40-$45 million laid a pretty good foundation for being comfortable with the direction of that particular pillar of ANI's growth. Under promising and over delivering is always a good policy going forward. BTW, RJ expects the rare disease segment to reach profitability during the 4th quarter 2022 based on the investment spend and Cortrophin's projected trajectory thru the end of the year.
Ascending Stock Price & Update ...
Good to see the stock above $38, let's hope it can stay there! Hit it briefly back in August (16th & 26th), then you have to go all the way back to February (17th) for it to close at or above that price. The current trend looks promising.
Back in March ANI filed an application to import the active ingredient in these particular fungi:
The substance Psilocybin (7437) will be used to support formulation development and clinical trial research.
In May the Company was granted their registration by the DEA:
DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic class(es) schedule I and II controlled substance(s) is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. DEA investigated each of the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, DEA has granted a registration as an importer for schedule I and II controlled substance(s) to the above-listed company.
It will be interesting to see if there is mention in the 3rd Quarter results.
Also, the Company has started a relationship back in June with Veeva that looks to be very helpful with the Cortrophin Gel sales franchise:
Leveraging #patientdata, ANI Pharmaceuticals enabled their field team with key information for a speedy product launch.
Learn how they pulled it off so quickly: https://bit.ly/3SyZ18t
Building on 100 years of success with generics and manufacturing, ANI Pharmaceuticals launched its first patented, branded rare disease therapeutic in January 2022, just 75 days after receiving FDA approval on its supplemental new drug application (sNDA) in November 2021.
That meant that within weeks, the company needed to fully understand the patient journey, potential prescribers and treatment patterns, and market landscape—and enable the field with insights from each.
Good Luck All!
H.C. Wainwright 24th Annual Global Investment Conference ...
Held yesterday at 12:30pm EDT :
Rescheduled Fireside Chat ...
The original date was last month. It's tentatively scheduled for tomorrow:
ANI Fireside Chat: Launching with Speed and Scale
When commercializing a new product, creating an effective launch plan is crucial for success. Join Mike Rifflard, Vice President, Operations - Rare Disease at ANI Pharmaceuticals, and Doug Caldwell, Vice President, Commercial Strategy at Veeva, in this 30-minute discussion to learn more about:
-How ANI prepared to launch its first product in its new Rare Disease Business Unit
-Key considerations when investing in commercial technology
-Key solutions that helped them launch with speed and scale for future success
Come prepared to ask your questions during the 15-minute Q&A following the discussion.
Aug 17, 2022 01:00 PM in Eastern Time (US and Canada)
BTW, nice premarket activity this morning.
All Things Considered ...
The share price is back to it's pre Ides of March debacle around $35/share, so that's a very positive sign going forward. The increase in revenue guidance for Cortrophin is the key! The first full quarter results pertaining to sales are impressive. The sales team is forming a solid foundation for accelerated growth in the near term as well as the foreseeable future, with this particular pillar established by the Company, as the leading one. This should benefit the share price over the next several Quarters.
From GoodRx Health ...
Below are excerpts from the list of the 20 most expensive Prescription Drugs in US:
19) Cortrophin gel – $31,851
Another drug approved in 2021, cortrophin gel is manufactured by ANI Pharmaceuticals. Cortrophin gel shares the same active ingredient as acthar gel and was developed to treat similar types of conditions, such as rheumatic disorders, collagen diseases, and dermatologic diseases.
People prescribed cortrophin gel will typically use one vial of the drug each month, bringing the total monthly cost of treatment to $31,851.
Some people may qualify for financial assistance through the Cortrophin In Your Corner Copay Savings Program.
Interestingly, Acthar Gel is #11 on the list:
11) Acthar gel – $41,459
Acthar gel, previously referred to as acthar, is used to treat multiple conditions like lupus, rheumatoid arthritis, multiple sclerosis, infantile spasms, ophthalmic conditions, and psoriatic arthritis. It is manufactured by Mallinckrodt Pharmaceuticals and was approved in 2010.
Just like many drugs on this list, Acthar has seen its fair share of price hikes. In 2001, when the drug was still manufactured by Sanofi, the list price for one vial ran at about $40. Twenty-one years and one new manufacturer later, the list price for one vial of Acthar (a typical monthly supply) now runs at $41,459.
Financial assistance is available through Mallinckrodt’s copay and patient assistance programs. You must meet certain criteria to be eligible.
Jersey Gets No Respect...
< Now with Novitium being less than 1.5 hours from New York City>
Having spent a few years in the state of New Jersey, I assure you that there are plenty of applicants not only within the State, but just to the southwest, is Philadelphia less than hour away, which is another major pharmaceutical hub in the megalopolis from Washington, D,C, to Boston (which also has their share of Biotechs). Honestly New York City really doesn't play into the whether attracting capable applicants or not, there are enough within an hour's drive of East Winsdor.
Just drive up from Philly to Princeton on US Route # 1 then up to North Jersey and you'll get the picture of the Pharma/Biotech industry in Jersey. Below are the Pharmaceutical Companies in New Jersey:
Novitium Pharma East Windsor, NJ Generics
This about improving the bottom line and as the Company has emphasized, Generics is one of the four pillars of the long term sustainable growth phase.
Also Novitium Pharmaceuticals provides a state of the art R & D facility which is essential to developing future drug candidates.
Top 10 Pharmaceutical Hubs in the USA
San Diego, CA. ...
Maryland/DC Metro. ...
Greater Philadelphia. ...
Seattle, WA. ...
Raleigh-Durham, NC. ...
Los Angeles, CA. ...
Chicago, IL. ...
Fire Sale on Light Volume ...
Caught the tail end of CC for Q & A . Focusing on new patients with Cortophin Gel. They said they are looking to expand the market rather than attempting to capture Acthar's share. Let's hope that the relationship's with the decision makers the sales team brought with them are only getting stronger!
The next several quarters are vitally important! This a brutal market and is unforgiving to one and all!
From Twin Cities Business ...
Here's an excerpt:
ANI Pharmaceuticals Banks on Rare Disease Business
The Baudette, Minnesota-based pharmaceutical company has sustained losses over its last three quarters, but its execs say it’s all part of a larger “transition.”
By Dan Niepow
April 12, 2022
Amid the dozens of publicly traded firms in Minnesota, Baudette-based ANI Pharmaceuticals Inc. often flies under the radar. The pharmaceutical company about five hours north of Minneapolis has grown largely by focusing on the market for generic drugs. In its most recent quarter, for instance, generics accounted for nearly 70 percent of the ANI’s revenue.
That may be changing in the near future, though. With FDA approval secured, the company is now betting on an obscure drug for rare diseases: Cortrophin Gel, which is used to treat autoimmune disorders in individuals who can’t tolerate steroids. ANI has even established its first rare disease business unit to chase more deals in the market.
“The rare disease business unit is the most important business unit for ANI,” said president and CEO Nikhil Lalwani. “It’s the one that will play a big role in the future growth of ANI.”
Raymond James Lowers Price Target ...
ANI Pharmaceuticals price target lowered from $65.00 to $47.00.
You Can Add ANI Pharmaceuticals ...
To the list of unfortunately events occurring on the Ides of March!
Disappointing CC from beginning to end. Was expecting initial sales numbers since announcing the commercial launch, Zilch! I can understand being cautious, waiting for 1st Quarter results to give numbers, but after spending millions for their pre-launch of Cortrophin Gel and not getting even a hint from Management of anything positive was virtually nonexistence! This is the only hint of sales in the 10-K:
Purified Cortrophin Gel became available to our customers in late 2021, and we recognized an immaterial amount of revenues during the year ended December 31, 2021. On January 24, 2022, we announced the full-scale U.S. commercial availability and launch of Purified Cortrophin Gel.
They better have that 50+ sales force team out there pounding the hell out of that pavement getting in front of physicians and decision makers or the
Cortrophin In Your Corner will be taking a standing 8 count!
The Ides of March ...
An ominous date in history:
Should get a good picture from the Company of the initiate sales figures of Cortrophin Gel:
Early this year, ANI Pharma launched Cortrophin Gel on a full-scale commercial basis, which is believed to be a transformational opportunity for the company and a potential significant growth driver with commercial longevity.
Cortrophin Gel is approved for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome.
Given the fact that the company is making considerable progress across its four key pillars of Cortrophin Gel franchise, Generics business, Established brands, and CDMO business, it is worth keeping an eye on ANIP.
Looking forward to the Q & A today!
Good luck to all!
Magic Mushrooms - Update ...
ANI has also applied for the following:
In accordance with 21 CFR 1301.33(a), this is notice that on January 6, 2022, ANI Pharmaceuticals, Inc., 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled substance Drug code Schedule
Psilocybin 7437 I
Psilocyn 7438 I
Levorphanol 9220 II
The company plans to bulk manufacture the listed controlled substances for the internal use or for sale to its customers. No other activities for these drug codes are authorized for this registration.
ANI has filed an application to import the active ingredient in these particular fungi:
The substance Psilocybin (7437) will be used to support formulation development and clinical trial research.
Psilocybin has shown in recent studies to have a beneficial effect with people suffering from depression:
There are currently 91 clinical studies on ClinicalTrials.org:
This is an interesting development that the Company is pursuing. Below is an informative article pertaining to the future of this particular treatment:
The Commercial Launch Has Begun ...
ANI Pharmaceuticals Announces Commercial Availability of Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) for Multiple Chronic Autoimmune Disorders
BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced the U.S. commercial availability of Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) 80 U/mL. The commercial launch of Cortrophin Gel, an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, is being led by ANI’s recently established rare disease business unit. Cortrophin Gel is indicated for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome. For full list of indications, please see below.
“Patients with certain chronic autoimmune conditions often need additional treatment options,” said Dr. Mary Pao Seideman, Chief Medical Officer of ANI. “ACTH therapy can be effective across a number of inflammatory diseases. The reintroduction of Cortrophin Gel gives prescribers another ACTH option, which can mean a greater chance for an effective treatment for some patients.”
“Choice in the ACTH category is long overdue, with only one available treatment option for over two decades. With today’s full-scale commercial launch of Cortrophin Gel, an established treatment, healthcare professionals now have another ACTH therapy option, with U.S.-based development, supply chain and manufacturing,” said Nikhil Lalwani, President and Chief Executive Officer of ANI. “This milestone is the culmination of six years of hard work and dedication from ANI employees and external partners, building on ANI’s long history and mission to create high-quality medicines for patients in need. I am extremely proud of the high-degree of technical excellence employed by our team in reintroducing this important treatment to a community long in need of alternatives.”
“Our goal from the start has been to ensure that Cortrophin Gel is available to as many patients who need it as possible,” said Christopher Mutz, Head of Rare Disease for ANI. “As part of our commitment to supporting meaningful access to Cortrophin Gel, we’ve launched our reimbursement and access support hub, Cortrophin in Your Corner™ to provide commercial copay support and other reimbursement assistance for eligible patients.”
Cortrophin Gel is now available to healthcare providers through a network of specialty pharmacies and distributors. For appropriate patients, physicians can submit a prescription and initiate access to treatment through a specialty pharmacy by visiting www.cortrophin.com.
ANI is committed to establishing meaningful access to Cortrophin Gel and has created Cortrophin In Your Corner, a dedicated program for patients and their caregivers throughout the treatment journey that includes one-on-one access and reimbursement support, financial assistance for eligible patients, and nurse-provided injection training. Cortrophin In Your Corner also provides access and reimbursement support for healthcare professionals and their staff. To get started with Cortrophin Gel, call Cortrophin In Your Corner (available Monday–Friday from 8 AM - 8 PM ET) at 1-800-805-5258.
Important Safety Information
Cortrophin Gel is contraindicated for intravenous administration.
Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources.
Warnings and Precautions
Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections.
Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation.
Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium.
Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of disease.
Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated.
Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.
Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response.
Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis.
Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease.
Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.
Growth and development: Carefully observe growth and development of infants and children on prolonged corticotropin therapy.
Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.
Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia.
Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; and suppression of growth in children. These are not all the adverse reactions reported with Cortrophin Gel.
Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for:
Short-term administration as an adjunctive therapy during an acute episode or exacerbation in rheumatoid arthritis, including juvenile rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; and acute gouty arthritis.
Exacerbations or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).
Severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis.
Atopic dermatitis and serum sickness.
Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.
Inducing a diuresis or remission of proteinuria due to nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
Acute exacerbations of multiple sclerosis.
Please click here for full prescribing information for Cortrophin Gel.
Humana Healthy Horizons™ in Florida
All Regions ...
Here is the most recent 2022 Preferred Drug Formulary:
THIS DOCUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN. THIS FORMULARY WAS UPDATED ON 01/18/20
CORTROPHIN GEL 80 UNIT/ML INJECTION PA,QL(45 per 30 days)
Prior Authorization (PA): Some drugs need to be approved by your plan to be covered
Quantity Limits (QL): You may have a limit on the amount of drugs you can get at one time.
No and Yes ...
Haven't purchased any shares recently, did buy some over a year & a half ago for around $32/share. This is a long term investment, as well, that will remain so for the foreseeable future. As for optimism, absolutely! The current management team has implemented a strong foundation for growth over the next several years with the four pillars. Now is the time to implement, the number one pillar, the execution of that strategy with the experienced team that has been assembled for the Cortrophin launch, with significant penetration of the market with an alternative to the only other competitor. The acquisition of Novitium, with their CMDO business and generics capability's, is another pillar(s) that will only add to the bottom line in short order. Yes, there is reason to be an optimist.
BTW, did purchase a few shares of Oramed Pharmaceuticals(ORMP) last month for under &15/share. Interesting concept. Issued annual message this morning:
The next year is going to be interesting for both of these investments.
Good Luck to all!