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lakers_w 410 posts  |  Last Activity: Jun 26, 2015 1:02 PM Member since: Jun 13, 2000
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  • Johnson & Johnson's New Billion-Dollar Blockbuster

    By Investopedia | April 17, 2015 AAA |

    Invokana, one of Johnson & Johnson's (NYSE: JNJ) newest drugs, was a bright spot in the company's otherwise lackluster first-quarter earnings report. Invokana's sales skyrocketed to $278 million in the first quarter, up from $94 million the year before, giving Invokana an annualized sales run rate that suggests it will achieve billion-dollar blockbuster status this year. Since Invokana is having a bigger impact on J&J's financial results, let's learn more about it and see whether its sales success can continue.

    Expanding markets
    The market for diabetes medication is growing alongside an older and heavier-set global population. According to the International Diabetes Federation, or IDF, the number of diabetics will climb 52.9% to 592 million people worldwide by 2035.

    A lot of that increase will occur in developed markets such as America, where there are more than 25 million people living with diabetes and 86 million pre-diabetics.

    Since millions of these pre-diabetes patients will eventually end up diagnosed with type 2 diabetes during their lifetime, demand for next-generation therapies that are designed to improve glycemic control should continue to climb for years to come.

    Billions of dollars and climbing
    According to IMS Health, U.S. spending on diabetes medication soared by 30.5% to $32.2 billion in 2014, and SGLT2 inhibitors such as Invokana are a major reason behind that spending increase.

    The FDA approved Invokana in 2013, but sales really took off after AstraZeneca (NYSE: AZN) won approval for its own SGLT2 inhibitor, Farxiga.

    Although the idea that a new competitor is boosting sales, rather than denting them, may seem counterintuitive, SGLT2 inhibitors represent an entirely new class of drugs, and as a result, a significant amount of education was necessary before doctors were willing to embrace them. Since AstraZeneca is a global leader

  • U.S. FDA warns on newer class of type 2 diabetes drugs

    The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization.

    The drugs belong to a class known as SGLT2 inhibitors that work by causing blood sugar to be secreted in the urine. They include AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana (canagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer.

    The FDA, in a warning on its website, said the medicines may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones.

    The FDA said its Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 to June 6, 2014. It said all patients required emergency room visits or hospitalization to treat the condition.

    Since June 2014, the agency said it had continued to receive additional adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors.

    The FDA warning also listed three combination type 2 diabetes treatments that include an SGLT2 drug as one of its two components, J&J's Invokamet, Xigduo XR from AstraZeneca and Lilly and Boehringer's Glyxambi.

    [Real insulin works better. AZ, JJ, Lilly are looking over their shouldesr wishing they have Afrezza. Jefferies wants investment banking biz from Mnkd. If GS behaves Mnkd may use them and Jefferies as co-leads in BO or LBO.]

  • SGLT2 INHIBITORS: DRUG SAFETY COMMUNICATION - FDA WARNS MEDICINES MAY RESULT IN A SERIOUS CONDITION OF TOO MUCH ACID IN THE BLOOD
    [Posted 05/15/2015]

    AUDIENCE: Endocrinology, Family Practice

    ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

    BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.

    These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin.

    RECOMMENDATION: Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber.

    Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels. See the FDA Drug Safety Communication for more information.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Jefferies Believes Additional Efforts by MannKind (MNKD) to Expand Afrezza Could Provide Upside

    Jefferies affirms MannKind (Nasdaq: MNKD) at Buy with a price target of $9 folloinwg a recent Afrezza survey.

    Analyst Shaunak Deepak said Jefferies surveyed 56 endocrinologists and primary care physicians about their expected use of Afrezza for diabetes.

    Deepak commented, In screening physicians, we found that 35 percent did not know about Afrezza. Those that did, however, expected to use Afrezza more frequently than we had expected, especially among Type 1 diabetics.

    On reasoning behind such a low launch, Deepak said, Ignorance is a big factor: of the 120 physicians screened for this survey, 35 percent were not familiar with Afrezza. Combined with the 8 percent who knew about Afrezza but did not expect to prescribe it, this suggests nearly half of potential prescribers are not currently writing Afrezza scripts. Indeed, only 12 doctors surveyed had written a prescription for Afrezza. Separately, in keeping with MNKD’s 1Q commentary that lung function testing was a gating factor for Afrezza uptake, prescribers who did not own a spirometer rated the test a 5/5 burden, compared to a 2.5/5 burden for those who did.

    But, Deepak maintains a Buy rating, commenting, Only a tenth of doctors screened had written an Afrezza script, we see MNKD’s efforts to expand access to spirometers and begin advertising in 3Q as key catalysts for uptake. With advertising, we expect the eventual rate of non-prescribers will fall closer to 12 percent. The 2015-2017 Afrezza use numbers implied by our survey suggest penetration rates nearly four times higher than we had previously modeled, and a $37 PT. To account for potential overreporting by surveyed physicians, we have discounted reported penetration rates by 70 percent and assumed that the reported 2017 penetration is a stand-in for peak.

  • ir.amphastarDOTcom/events.cfm

    Click pdf file Amphastar Pharmaceuticals, Inc.
    Investor Presentation
    May 2015

  • lakers_w lakers_w May 14, 2015 12:11 AM Flag

    Serge Belanger
    Hi. Good afternoon. A couple of question on the AFP insulin business just wanted to know where you are in the process to ramp up production and if at this point or in the near future the businesses will be profitable?
    Jason Shandell
    We are in the process of ramping up I will say that first quarter production of insulin was the highest that we've had since we purchased the facility and we’re definitely making progress there but we’re not up as high as we eventually planned to be by the end of this year and when the 10-Q does come out tomorrow you will be able to see because we do have the segment disclosure in the 10-Q so you will be able to see that we did have a profit on the gross profit level on this business this time of about $427,000 and that was on 6.014 million in sales for the quarter so that that's a little bit of a turnaround from the negative gross margins that we had last year so we are making progress on that effort and overall the business does still lose money but in the long run we will be making money in that business and that's going to serve the Company strategically in the long run.
    Bill Peters
    And on the capacity we continue to make strides in that there is various areas that in the chain that can be improved with respect to capacity and then to the overall question for the upstream technology transfer that was part of that agreement that's a multiple year effort but will ultimately will significantly bring the cost down once the inclusion bodies are also manufactured in the French facility.
    Serge Belanger
    Yes, so that inclusion body process is three years.
    Bill Peters
    Yes, right that's correct.
    Serge Belanger
    Okay. And how will the business be impacted as mankind ramps up manufacturing of their product?
    Bill Peters
    Well. Right now it doesn't -- what matters to us is really not how much they manufacture but how much we sell to them because they have minimum commitments that they have to buy from us on an annual basis for five years starting this year and then as a reminder they also signed an option contract in the first quarter where they could potentially purchase even higher quantities in 2016-2017-2018-2019 so for us it's not a matter of how much they make but a matter of getting up to speed so that we can supply them and our existing customers and also have additional spare capacity so that we could potentially service certain customers of ours who have filings in other countries who might move from R&D purchase levels right now to production level purchases at some point in the future

  • lakers_w lakers_w May 13, 2015 5:17 PM Flag

    6:03 am Amphastar Pharmaceuticals beats by $0.05, beats on revs (AMPH) : Reports Q1 (Mar) loss of $0.01 per share, $0.05 better than the Capital IQ Consensus Estimate of ($0.06); revenues rose 24.0% year/year to $56.9 mln vs the $54.02 mln consensus.

    •The proprietary pipeline includes a new drug application, or NDA, for Primatene and an NDA supplement for Amphadase. The Company is currently developing six other proprietary drugs including injectables, inhalation products, and other dosage forms.

    Sales of the Company's insulin API products were $6.0 million during the quarter.

    Cost of revenues were $43.6 million, or 77% of revenues, and $33.4 million, or 73% of revenues, for the three months ended March 31, 2015 and 2014, respectively, representing an increase of $10.2 million, or 31%. This increase was primarily due to the cost of revenues at the Company's French subsidiary, AFP, as the Company prepared to increase production to meet demand in connection with its supply agreement with MannKind. Decreases in the average selling price of enoxaparin also contributed to the increase in cost of revenues on a percentage basis.

  • lakers_w lakers_w May 13, 2015 2:50 PM Flag

    Be sure to listen in this important CC.

  • jonesmedicalDOTcom/afrezza/

    You may have read or heard about a new form of insulin that is inhaled through the mouth into the lungs instead of injected. The availability of inhalable insulin is long-awaited news for people with diabetes. In June 2014 the FDA approved Afrezza®, a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Because of the effect of Afrezza® on pulmonary function, all patients must have spirometry assessed prior to initiating therapy and regularly thereafter.

    Because this is a new indication for spirometry testing there are a lot of questions about spirometer selection, staff training, and reimbursement. The spirometry testing requirements for Afrezza® not only include initial qualification but indefinite monitoring; consequently, purchasing a spirometer that is easy, accurate, maintenance-free, and reimbursable should be a priority.

    We're here to help.
    Spirometry should be easy and seamlessly integrate into your workflow

    Utilizing the resources below will help guide your spirometer selection, streamline your testing & tracking, and clarify coding & reimbursement specific to the screening of Afrezza® patients.

    Spirometer Requirements
    & Selection Solution

    Click Here


    Reimbursement
    & Coding Solution

    Click Here


    Spirometry Tracking
    & Scheduling Solution

    Click Here


    The following is general information in regard to the required use of spirometry for Afrezza® patient selection and follow up monitoring. Full Prescribing Information can and should be obtained by contacting Sanofi US (distributor).

    Prior to initiating Afrezza® therapy:

    Afrezza® is contraindicated in patients with chronic lung disease such as asthma or COPD because of the risk of acute bronchospasm in these patients. Before initiating Afrezza®, perform a medical history, physical examination and spirometry (FEV1) in all patients to identify potential lung disease.

    The safety and efficacy of Afrezza® in patients

  • Mnkd to Announce $25M Mfgr milestone receipt for line 2, 3 CMC cert.

  • Reply to

    Mnkd may license out BluHale® Technology

    by lakers_w May 12, 2015 7:51 PM
    lakers_w lakers_w May 12, 2015 8:03 PM Flag

    For example, our BluHale technology is a novel inhalation profiling tool that uses miniature acoustic sensors to assess the drug delivery process. This provides unmatched insight to patient usage, device system performance and pharmacokinetic effects.

    Other innovative approaches include our anatomically correct airway models (ACAs) and our MIDAS system, our novel methodology for particle sizing. In combination, these tools enable rapid progression of your drug delivery program with our easy to use, breath-powered Cricket single-use or DreamBoat multi-dose inhaler systems.

    Patient Simulation

    Anatomy and physiology are critical elements of pulmonary drug delivery.

    To better understand the dispersion and delivery mechanics from a user perspective, MannKind incorporates anatomically correct airway (ACA) models. We also link the ACA with the user's physiology to improve the drug development process.

    Our resulting MIDAS (MannKind Inhalation Data Automated Simulator) system is a proprietary, custom-designed, mechanical pump that creates and/or replicates user inspiratory efforts. This enables us to gain insight into patient inspiratory profiles for specific populations, including:
    •Elderly
    •COPD patients
    •Pediatrics

    In combination with ACA models, the pulmonary delivery process can then be simulated within the lab setting with unrivaled user perspective.
    mannkindtechnologiesDOTcom/AdvancedDevelopmentTechnology/PatientSimulation.aspx

  • mannkindtechnologiesDOTcom/AdvancedDevelopmentTechnology/BluHaleTechnology.aspx
    has been updated.
    "In addition, MannKind is applying our novel technologies and services to support partner development efforts. "

    BluHale® Technology

    Mannkind Corporation employs a compact, wireless pressure profiling technology called BluHale® to develop its breath powered, dry powder delivery systems (device plus formulation).

    BluHale is used to monitor inhalation by a real patient population, which allows us to modify our dry powder delivery systems for optimal pulmonary drug delivery. BluHale is also used to reduce unwanted variability during clinical studies and for patient training on approved drug therapies.

    During inhalation, pressure-time profiles are transmitted wirelessly, in real time, to a graphical user interface (GUI), enabling subjects to meet a required inhalation effort. Its use assures our delivery devices are precisely engineered to meet patient and therapeutic need.

    In BluHale technology, a small discreet electro-acoustic device, housed in a jacket-like frame, affixes to a dry powder inhaler (DPI) and measures the sound generated during device use. The sound signal is calibrated to the applied pressure drop.

    Unlike traditional pressure/flow sensors, the BluHale technology has many advantages:
    •The device/patient interface is unchanged during data collection because of its small size
    •Data capture can occur with or without drug administration because the sensor can be placed remotely
    •The discreet sensor can be housed in any frame for easy adaptability onto all inhaler types
    •The interactive aspect of real-time data capture enables subjects to achieve prescribed inhalation efforts accurately

  • mnkd.proboardsDOTcom/thread/2430/afrezza-on-diabetic-living-magazine?page=1#scrollTo=25290

  • goodrxDOTcom/afrezza

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  • lakers_w lakers_w May 12, 2015 6:23 PM Flag

    depreciation of facility, which is a non-cash charge. We get that recouped at this point, but they are substantially paying for the past production and cost of building the facility as part of the margin here. So it generates cash for us, but it’s still technically considered at cost for the contract.

    Hakan Edstrom - Chief Executive Officer
    Well, what I can say is that on a regional basis, Sanofi has assigned specific responsibility in terms of bringing these separate activities together and in helping the physician, helping patients, and helping the reps, get it all together. So it’s almost like you could say you have kind of a concierge service within the region, within the territories that are healthy to streamline decision and also going forward in regard to what Al mentioned on the spirometer side in making sure that at least administratively we make it as convenient as possible and not a major obstacle.

    I certainly see that number of prescriptions did increase recently rather significant over the last couple of two weeks.

    Matthew Pfeffer

    We certainly know very specifically what Sanofi is planning to do, but we can’t disclose all of those things. Unfortunately, some of these issues will go away naturally. They have a very large reimbursement organization; they are working with the insurance companies, you should expect that to the extent to get [indiscernible] position.

    Some of these prior authorization issues will naturally go away. In the mean time, there is a lot of things they can do to make it easier for the doctors than you would expect they would do that. And there is other things they can do as well that we are not allowed to talk about, but we’re quite pleased that they are taking a very stance and working on them.

  • lakers_w lakers_w May 12, 2015 6:17 PM Flag

    Steve Byrne - Bank of America Merrill Lynch
    Well, you mentioned the $7.1 million, Matt, that $7.1 million of deferred sales and the $6.3 million of deferred costs. Is that essentially product that was delivered in investments in inventory versus what was sold?
    Matthew Pfeffer - Chief Financial Officer
    Okay. So those are actual sales to Sanofi. Those are the numbers we are reporting. They are not shown on the P&L because all of those things are deferred. They are hung up on the balance sheet. You can think about it as a sales and cost of goods number related to products transferred to Sanofi during the quarter. But that’s all sales for them, including things like samples and potentially in the future clinical supply. So, some of it was sold to end-users, some of it’s in their inventory, in Sanofi’s hand, and some of it’s been given away for free.
    Steve Byrne - Bank of America Merrill Lynch
    Okay. And the difference between those two numbers is that your mark up on cost of goods?
    Matthew Pfeffer - Chief Financial Officer
    It represents – you can think of it that way. There is not technically according to the contract a mark up on cost of goods, but we are allowed to recoup some cost that we’ve previously expensed as part of this process. So from an accounting standpoint, we show a slight margin in the near-term, but technically it’s considered to be for Sanofi’s purposes at our cost.

    So we make the money from selling things to them, when they sell it, we make a profit later on down the road. But for example, it’s well known that we have a lot of insulin in inventory and we did buy that once upon a time, but we expensed it when we did to the extent we now use that in manufacturing of our products. We can charge Sanofi for what it cost us originally so we kind of recoup it now and it shows up as margin. So we have an accounting margin.

    And we’ve always have positive cash flow. Of course, in the production of products, you include things like amortization or depreciati

  • twitterDOTcom/PatOppa/status/576453812484980736/photo/1
    Walmart Pharmacy Receipts Picture.

    Afrezza: 2 boxes, 60x8u, 30x4u = 1,200 . Cash Price = $630.17, $0.53/unit. Patient pays: $30, 3/13/15

    Humanlog: 10 KWIKPENS, 3,000u. Cash Price = $956.04, $0.32/unit, not incl. needle cost. Patient pays: $60, 3/12/15

  • MannKind Corporation: Afrezza Prescriptions Picking Up

    MannKind released its latest earnings report on May 8, and Wall Street was generally disappointed. However, not everyone is so bearish on the inhaled insulin maker. RBC Capital Markets analysts say it’s no surprise how slowly the Afrezza launch is going, and they’re not worried.

    Afrezza growth coming slowly

    RBC analyst Adnan Butt and his team have been tracking Afrezza prescriptions week by week. The week ending May 1, marked the 15th week in which Afrezza prescriptions could be written, They reported that there were 258 total prescriptions for the inhaled insulin written that week, marking a growth rate of 18.9% from the previous week’s 217 prescriptions. There were 200 new prescriptions for Afrezza written, a 23.5% growth rate compared to the previous week’s 162 new prescriptions.

    They reported that MannKind’s share of the insulin market increased slightly week over week, edging up from 0.06% to 0.07% the week ending May 1. That compares to Apidra’s 2.87% share, a slight decline from the previous week’s market share. Humalog held 40.35% of the market, a slight decline from the previous week’s 40.4%, and Novalog increased its share from 46.1% to 46.27% of the market.

    Here’s a look at their estimates regarding market share for Afrezza compared to its two closes competitors ( Graphs are courtesy RBC Capital Markets.):

    Analysis of MannKind’s earnings report

    Marketing partner Sanofi had said the day before MannKind’s earnings reports that Afrezza sales were about $1.1 million during the first quarter. The drug maker also said MannKind’s share of the joint venture losses was $12.4 million. The insulin maker ended up posting losses of 8 cents per share on the back of lower operating expenses, which was in line with consensus estimates.

    MannKind ended the first quarter with about $121 million in cash and guided for general and administrative expenses of between $10 million and $12 million per quarter. The drug maker guided for about $12 million or less in research and development spending. Investors are focused on MannKind’s cash levels because the company has about $104 million in convertible debt due this year. Management said they expect to refinance that amount with debt but have not provided guidance on cash levels.

    Too early for MannKind to celebrate

    The RBC Capital Markets team added that the hurdles MannKind has faced so far in launching Afrezza were expected and that some can probably be fixed. Unsurprisingly, the requirement of lung function testing in patients, many doctor appointments, requirement for 10-day samples and pushback from insurance companies were all expected.

    But they think these issues will be fixed over time. They aren’t expecting much in the first six to nine months of Afrezza’s launch. Further, they say it’s a positive that prescription data has picked up and that they think patients who don’t like needles could start asking for Afrezza prescriptions starting in the third quarter of the year.

    MannKind’s partnership with Sanofi could continue

    They expect Sanofi to remain committed to Afrezza for the next year to year-and-a-half because of the company’s loan facility. Some signs of Sanofi’s commitment include continued support programs for patients, direct advertising and clinical studies aimed at improving the label on the insulin.

    The RBC team expects MannKind shares to remain range-bound for now unless Sanofi makes specific commitments regarding its partnership on Afrezza, there’s a pick-up in demand, or the pipeline is more developed further. They think the trajectory of the inhaled insulin over the next three to four years is more important than profitability right now.

    The analysts continue to rate MannKind at Outperform with a target price of $10 per share.

  • MannKind: Afrezza's slow start due to delays not demand for inhalable insulin

    By Dan Stanton, 12-May-2015

    Sanofi's inhaled insulin drug Affrezza has generated lower than expected revenue due to marketing delays rather than low demand according to MannKind CFO, Matthew Pfeffer.

    in-pharmatechnologistDOTcom/Drug-Delivery/Slow-start-for-Sanofi-and-MannKind-s-inhalable-insulin-Afrezza

  • Reasons for Optimism
    We believe there are several reasons to think demand for Afrezza will strengthen soon. Since its launch in February, sales of MannKind’s inhalable insulin have trended upward. However, the volume in the March quarter was light and the pace of business in the current quarter has continued along the same trajectory. Prospects should begin to change in the second half of this year; here’s why:
    IInsurance coverage of Afrezza should become more favorable starting in the September quarter. The reason for the change is simple – most insurers provide limited coverage for new drugs during their first six months on the market. In Afrezza’s case, some have initiated coverage, but with a tier 3 co- pay, which is typically in the neighborhood of $50 per prescription. Others have been reimbursing for it on a case- by- case basis, and that approach is extremely slow since it requires extra effort from the pharmacist, prescribing physician, and insurer before coverage is approved. The reimbursement environment should begin to improve in August when Afrezza will hit its six- month anniversary. At that time, the drug will be eligible (in some cases automatically) for a more favorable tier, probably one that requires only a $20 co- pay.
    I Sanofi’s marketing efforts should strengthen. The company has already split its diabetes salesforce into three groups with one dedicated to Afrezza, another to its new long- acting insulin Toujeo, and a third to support both drugs. This came after the entire organization was trained on Afrezza so that all reps would be familiar with it. The dedicated Afrezza team now has “ownership” over the drug’s success, which figures importantly in Sanofi’s plans for its diabetes franchise. In addition, marketing efforts, which have been largely print advertisements in diabetes- related publications and for doctors’ offices, will expand to include direct-to- consumer ads.
    I MannKind will expand the dosage strengths available. The FDA has already approved a 12 unit cartridge, which should launch in mid- summer, to complement the 4 and 8 unit cartridges now available. A fourth, 2- unit cartridge may well follow since the FDA wants a post- marketing study to include children as young as 4 years old. Meanwhile, production capacity will expand by more than 3- fold in the June quarter.
    We are maintaining our BUY recommendation and $16.25 price target, given the favorable near-term events.

SNPS
49.92-0.32(-0.64%)Jul 2 4:00 PMEDT